Prescription drug costs significantly contribute to escalating healthcare expenditures in the United States and are a primary concern for many Americans.1 In comparison to other wealthy nations, individuals in the U.S. pay over 2.5 times more for their medications.1 As drug prices increase, so does the financial strain on payers and patients, which leads to increased drug spending for all stakeholders within the healthcare system. Addressing the challenge of ballooning prescription drug costs requires novel strategies that involve stakeholders at various levels to ensure equitable access to essential medications, financial stability and continued innovation in the healthcare system.
The Synergie Medication Collective, a new medication contracting organization, aims to tackle this challenge by focusing on improving affordability and access to medical benefit drugs.2 Synergie is an independent organization founded by a group of Blue Cross Blue Shield-affiliated companies, including investors such as the Blue Cross Blue Shield Association (BCBSA), Elevance Health, Evio Pharmacy Solutions, Prime Therapeutics and other independent health plans.2 They were founded with the common goal of improving the quality and value of care for patients who require costly treatments covered under the medical benefit.2
Medical benefit drugs are medications that are administered in a healthcare provider’s office, typically via infusion or injection, and are given by a healthcare professional.2 These medical drugs, such as infusible oncology treatments or gene therapies, often are associated with high costs, with cell and gene therapies reaching up to a staggering $3.5 million per therapy.2 These particularly costly treatments represent a substantial and growing portion of total drug spending, with more than 3,869 cell and gene therapies currently in development.2
As medications covered under the medical benefit continue to see increased utilization and rising costs, Synergie fills an unmet need for patients requiring treatments for rare and complex diseases. Synergie will provide payers the opportunity to manage rising costs via negotiating power for medical drugs.3 Similar to the function of a pharmacy benefit manager (PBM) for pharmacy benefit drugs, Synergie reduces the cost of medical drugs through broader negotiation and shared systems, data and other tools.3 By building upon its collective reach and existing engagements with pharmaceutical manufacturers, Synergie aims to establish a more efficient contracting model to deliver cost savings and increased value to its health plan member organizations.3
The vision of Synergie is reflected in its company pillars: improving affordability and access, accelerating innovations and increasing efficiency.2 By emphasizing transparency in medical drug pricing, Synergie’s goal is to safeguard access to affordable treatments for nearly 100 million members.2-4 Synergie utilizes innovative value-based financial models in partnership with pharmaceutical manufacturers and other industry stakeholders to guarantee that the clinical value of these high-cost treatments is being realized by its member companies, linking the treatment costs to the clinical outcomes achieved.2 By positioning itself as a single point of contact for contract negotiations, Synergie targets increasing efficiencies and reducing administrative burdens for its members.2
The collective’s first product solutions to market are two offerings under their SelectMed+ product suite, which are available through participating health plans that have implemented these products into their medical offerings. The anticipated launch of SelectMed+ Rebates and Cell & Gene+ marks the beginning of what is expected to be a series of offerings within SelectMed+. These initiatives aim to support Synergie’s mission of enhancing affordability within the medical drug sector.2
The SelectMed+ Rebates program is a medical rebate contracting initiative that partners with pharmaceutical manufacturers to secure rebates for their participating member companies.2 Through an annual bidding process, Synergie formulates a comprehensive list of more than 100 medical drugs that are recommended to its participating plans as preferred based on optimizing cost and clinical outcomes.2 The list of preferred medications underscores a lowest net-cost approach and, as the collective is a pass-through organization, all savings are transferred to the participating health plan. Notably, decisions regarding product coverage and medical policy guidelines remain the independent prerogative of participating health plans, exercised at their sole discretion.2
With cell and gene therapy costs projected to increase at a rate of 40% over the next three years, plan sponsors are looking for solutions to aid in managing rising costs and promoting treatment access.2 The second offering in the SelectMed+ product suite, Cell & Gene+, is an integrated solutions portfolio specifically for cell and gene therapies.2 One component of the platform is a Gene+ Risk Protection product, which provides protection against financial volatility associated with the up-front costs of gene therapy treatments.2 The second component, Cell & Gene+ Patient Navigation, connects patients with top-quality treatment centers across the U.S. to ensure access to the best care teams for those undergoing these therapies.2 The third component in the offering is Gene+ Outcomes, which partners with pharmaceutical manufacturers in value-based contracts that hold the manufacturer accountable for patient outcomes.2 If the treatment does not achieve its predefined clinical outcome within the stated time frame, the manufacturer is required to provide refunds for the treatment based on the value agreement.2 These three modules that make up the Cell & Gene+ program enable access to vital and life-saving cell and gene therapies for patients while lessening the financial burden and risk for the payer.
The utilization of prescription drugs in the U.S. has grown; it increased by 9.6% from 2016 to 2021.5 The total expenditures of prescription drugs, adjusted for inflation, soared from $520 billion to $603 billion during that time, marking a 16% surge that far outpaced increased utilization.1 The disproportionate rise in spending relative to usage implies that the primary factor spurring escalating costs is increased spending per prescription.1 Specialty medications are the major driver of drug spending, with the cost of specialty drugs totaling $301 billion in 2021, a 43% increase from 2016.1 Specialty drugs dominate prescription drug expenditures; in 2021, specialty medications accounted for more than 40% of retail drug spending and almost 70% of nonretail drug spending.1 Despite the volume of prescriptions for specialty medications remaining largely flat, costs have steadily increased, with the top 10% of drugs by price making up less than 1% of the share of total prescriptions.1
As specialty drug costs are rising, the location where Americans receive their medications is changing. More drug spending is shifting to clinics and home healthcare as the administration of many of these specialty products is performed by a healthcare provider. Drug spending saw a 45% increase in clinic settings and a 95% increase in home healthcare settings from 2016 to 2021, indicating significant growth in the use of medical drugs.1
Projections for future drug trends anticipate drug spending to grow between 1% to 4% on a list price basis, driven largely by the prospective launches of innovative products in oncology or with specialty or orphan status.6 On average, an anticipated 50 to 55 new medication entities are expected to launch annually over the next five years.6 These products, including infusible cancer drugs and multimillion-dollar gene therapies, are predicted to put an unprecedented strain on the affordability of the healthcare system.
Owing to the substantial growth in medical drug trends and future outlook, payers will need to look to creative solutions to ensure sustainability and promote medication access. The traditional prescription drug management model, executed primarily by PBMs and managed care organizations, will need to evolve to meet this challenge. Innovative approaches to medication management will be essential to promote affordability and cost efficiency. Synergie endeavors to meet these needs by building solutions to help payers manage costs and ensure equitable treatment access to these costly medications.2
The SelectMed+ Medical Drug List embraces a lowest net-cost approach, factoring in medical rebates and clinical and cost-effectiveness evaluation in product selection.2 If participating health plans choose to align strongly with the recommended products, Synergie promises to deliver savings across multiple therapeutic categories, particularly in areas that have increased competition, such as biosimilars.2
Biosimilars represent a significant opportunity for payers to tackle the escalating costs of biologic medications while expanding access to treatment alternatives. Biosimilar products, or competitor products that are highly similar to existing biologics, closely resemble FDA-approved reference products without any clinically significant distinctions.7 The introduction of lower-cost biosimilars drives market competition and leads to declines in drug costs for both originators and biosimilars over time.8
The FDA has approved 45 biosimilars across 14 unique biological molecules as of January 2024; 38 of those biosimilars were launched in the U.S.9 (Figure 1). With the majority of entrants launching after 2017, biosimilars have had varying degrees of success in securing market share previously held by the biological reference products.10 Currently, biosimilars make up 25% of the total volume of prescriptions for reference molecules in the U.S.6 In the brief U.S. market experience with biosimilars, each molecule has demonstrated unique biosimilar uptake and may be influenced by many factors, including the number of competitor products to launch, the pricing strategy discount compared to the reference product, their interchangeable status and the availability of unbranded biologics or biological reference products that are marketed without their brand name or proprietary name.10,11,12 Over time, significant price decreases have been seen with both the biosimilar products and the reference molecules, with average sales price (ASP) declining, on average, by 41% in the three years following the first biosimilar launch (Figure 2).11 As additional competitors arrive and the biosimilar landscape matures, further price declines are anticipated, which will benefit both patients and payers by making biologic treatments more affordable and accessible. Synergie’s SelectMed+ Medical Drug List takes advantage of these market dynamics by placing one or more biosimilars in a preferred position across multiple clinical categories.2
Synergie will not be administering any utilization management (UM) on its drug list, but to help health plans achieve the greatest affordability, its recommendations will have an association with clinically appropriate UM strategies, which the health plan may independently choose to adopt.3 Synergie touts that all savings opportunities will be passed on to the participating payers, not retained to boost its own profits.3
Cell and gene therapies are also included in the SelectMed+ Medical Drug List and are selected based on the total value and cost savings with these potentially multimillion-dollar treatments.2 Therapies may be excluded if they are considered not medically necessary or if their clinical profile is deemed investigational.2 In addition, Synergie acknowledges that providers play a crucial role in ensuring the delivery of cell and gene therapies to patients and achieving optimal patient outcomes.3 Synergie seeks to engage in a collaborative model with providers, manufacturers and payers to develop effective value-based models for these emerging medical drug treatments.2
With its focus on medical drugs and integrated management across all industry stakeholders, Synergie is creating a novel approach to the management of these high-cost specialty treatments.2 Citing its goal of reducing the costs of specialty medications for payers and consumers, Synergie will make use of its existing networks and collective reach to enhance its negotiating power and medication delivery channels.2 While Synergie may compete with specialty pharmacies initially, Synergie intends to set itself apart by providing more services and expanding its offerings across its portfolio, measuring its success on its continued innovation and growth.3
Managed care decision-makers will be anxiously awaiting the results of Synergie’s program impact. As improving affordability is its most championed goal, the managed care community will want to see evidence of cost savings. Comparison of total drug spending before and after program implementation can be considered, with the caveat that the evaluated products may be limited to the medications on the collective’s drug list and may not be applicable to a plan sponsor’s total medical drug spend. Health outcome improvements could be another metric to capture program success and may translate to decreased medical spending for the payer. This could include measures such as reductions in disease progression, reduced hospitalization rates and emergency room avoidance, and decreased mortality.
Patient medication adherence may be a concern with medical drugs that may carry a high patient coinsurance burden or are associated with serious adverse reactions. Monitoring patient adherence rates among members who utilize Synergie’s preferred medications compared to those who do not might prove to be a valuable tool in assessing program success. Patient-reported metrics such as patient experience and satisfaction could be another way to quantify the potential impact of Synergie’s initiatives. Positive feedback regarding patients’ ease of access to medications and overall experience would suggest that the program is meeting patient needs and preferences. Lastly, provider engagement and collaboration should be assessed in utilizing the collective’s preferred medications and value-based models. Strong provider participation indicates acceptance and support for Synergie’s initiatives, which can lead to better patient outcomes and increased cost savings.
By analyzing these metrics and indicators, managed care decision-makers can effectively quantify the potential impact of Synergie’s initiatives on cost savings, medication adherence, health outcomes and overall healthcare quality for their members.
While the collective’s initial program offerings aim to reduce costs for participating health plans and plan sponsors, there are several remaining unmet needs. Synergie works with health plans to find cost savings and improve access to medications for their members, however, there remains a significant gap for uninsured individuals who may not have access to these negotiated discounts. Finding ways to extend Synergie’s benefits or similar cost-saving initiatives to these individuals could help address this gap and improve access to affordable medications for all patients.
Cell and gene therapies often come with significant ancillary costs beyond the drug itself, including administration, monitoring and supportive care. Patients may have to travel to receive these treatments or be hospitalized for monitoring after receiving therapy. These ancillary costs can add to the financial burden for patients and payers. Synergie could explore strategies to reduce these ancillary costs, such as negotiating bundled pricing arrangements with healthcare providers or developing innovative reimbursement models that include these ancillary services as part of the overall treatment package.
Implementing patient assistance programs or financial support mechanisms for individuals facing financial barriers to accessing cell and gene therapies could help address affordability challenges. These programs could provide financial assistance for out-of-pocket costs, copayments or deductibles associated with these high-cost treatments, ensuring that patients have access to life-saving therapies regardless of their ability to pay.
Many cell and gene therapies are relatively new and have limited long-term data on their efficacy and safety. Establishing robust long-term monitoring initiatives to track patient outcomes and safety profiles could help address uncertainties and build confidence in these therapies among patients, providers and payers.
Addressing these remaining unmet needs will be crucial for Synergie and similar programs to fulfill their mission of improving affordability, access and outcomes for patients requiring costly medical drug treatments. Stakeholder collaboration, innovative financing models and patient-centered approaches will be key strategies for overcoming these challenges and ensuring that all patients have access to the care they need.
Building upon its current offerings, Synergie Medication Collective has several future directions and opportunities for growth. While the collective initially will focus on high-cost medical benefit drugs, there is the potential for expansion into other areas of medication coverage. This could include medications that are expensive but do not necessarily cost many millions of dollars, such as specialty pharmaceuticals that are used in chronic diseases like rheumatoid arthritis or multiple sclerosis. By broadening its coverage scope, Synergie can address a wider range of healthcare needs and provide value to a larger population. There may also be opportunities for expansion into the pharmacy benefits space. This could involve partnering with PBMs or incorporating pharmacy benefit drugs into Synergie’s contracting and cost-saving initiatives. By expanding into the pharmacy benefits space, Synergie can offer comprehensive medication coverage and cost-saving solutions to health plans and their members.
Expanding on its present partnerships, Synergie can continue to collaborate with stakeholders across the healthcare ecosystem, including medication delivery channels, patient support services and patient advocacy groups. By leveraging collective expertise and resources, Synergie can drive innovation, improve medication access and deliver value to all stakeholders.
Regarding who will absorb the savings generated by Synergie’s initiatives, it will likely vary depending on the specific contractual agreements between the collective, health plans and pharmaceutical manufacturers. In some cases, savings may be absorbed by payers in the form of reduced medication costs. In other cases, savings may be shared between payers and patients through lower copayments or out-of-pocket expenses. Despite Synergie’s efforts to negotiate cost-savings agreements and promote access to medications, certain beneficiaries may still face barriers to affordability. This includes beneficiaries who are subject to list prices for medications, those with high out-of-pocket costs due to coinsurance or high deductibles and individuals who have plan designs where rebates are not passed through at the point of sale. Ultimately, the distribution of savings will depend on the terms negotiated between Synergie and its partners.
The collective may face challenges as it seeks to implement its initiatives and achieve its goals. The healthcare industry, particularly PBMs, has come under intense scrutiny from regulators and legislators. Synergie will need to navigate potential regulatory changes and legislative initiatives that could impact its operations and business model. Staying compliant with evolving regulations and maintaining transparency in its practices will be essential for Synergie to avoid negative perceptions and regulatory scrutiny.
With its value-based care initiative, Synergie aims to shift reimbursement from traditional fee-for-service models to models that reward providers based on the quality and outcomes of care delivered.2 One such value-based care initiative is the Centers for Medicare & Medicaid Services (CMS) Enhancing Oncology Model (EOM), which is a voluntary payment model for clinicians caring for Medicare patients with common cancer types.13 The EOM provides practices with monthly payments to fund activities focused on enhanced patient experience, quality improvement and cost-saving measures.13 Clinicians have the opportunity to earn additional bonuses if they meet quality targets and keep total costs of care below estimated benchmarks.13 However, there are also penalties for practices that exceed cost benchmarks, providing both financial incentives and accountability for managing costs.13 The data on bundled payments leading to cost savings have been mixed, suggesting that stronger economic incentives may be needed to drive meaningful changes in practice behavior and outcomes.13
Synergie’s Cell & Gene+ offering represents an innovative step toward value-based care in cell and gene therapy treatments. A notable difference from the EOM is that Synergie’s initiative includes a provision for manufacturers to provide refunds to payers if patients do not achieve predefined clinical outcomes within a specified time frame.2 This approach directly ties payment to patient outcomes, incentivizing manufacturers to develop effective therapies and ensuring that payers only pay for treatments that deliver the intended clinical benefits. This alignment may lead to more effective therapies and improved patient outcomes over time.
The escalating costs of medical drugs, underscored by the astronomical prices of cell and gene therapies that may cost $2 million to $3 million per treatment, have highlighted the urgent need to lower healthcare costs and improve access to medications. Rising drug spending not only strains payer budgets but also impedes patients’ ability to afford life-saving treatments. By focusing on improving the quality of care and ensuring access to medications, patients living with complex conditions can experience better disease management, reduced hospitalizations, less frequent healthcare utilization and improved overall quality of life.
Amid the projected increase in oncology and rare-disease drug approvals, specialty pharmacies will position themselves as central players in the healthcare ecosystem by engaging with patients, providers, facilities and distribution channels. With a pioneering approach to medical drug management, the Synergie Medication Collective emerges with a clear mission: to implement value-based models that provide cost-effective and sustainably priced medications, ultimately enhancing accessibility for patients in need.
Currently focusing on medical benefit medications, Synergie’s innovative product offerings, such as SelectMed+ Rebates and Cell & Gene+, aim to revolutionize the landscape by negotiating value-based contracts and providing cost-savings solutions. These initiatives not only drive down medication costs but also incentivize better patient outcomes and quality of care. Looking ahead, Synergie aims to expand its transformative value-based models, potentially disrupting the status quo in medication pricing and accessibility. By forging partnerships and leveraging collective expertise, Synergie aspires to be at the forefront of driving positive change in the healthcare industry, ensuring that patients have access to the medications they need to live healthier, fuller lives.
References
1. Parasrampuria S, Murphy S. Trends in prescription drug spending, 2016-2021. Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. September 30, 2022. Accessed February 5, 2024. https://aspe.hhs.gov/reports/trends-prescription-drug-spending
2. Lowering medication costs and improving access to care for millions. Synergie Medication Collective. Accessed February 5, 2024. https://www.synergiecollective.com/
3. Maas A. new organization will focus on medical benefit drugs. MMITNetwork. January 19, 2023. Accessed February 5, 2024. https://www.mmitnetwork.com/ aishealth/spotlight-on-market-access/new-organization-will-focus-on-medical-benefit-drugs-2/
4. Blue Cross Blue Shield companies form Synergie Medication Collective, a new venture to radically improve affordability and access to costly medications for millions of Americans. Blue Cross Blue Shield. January 5, 2023. Accessed February 6, 2024. https://www.bcbs.com/press-releases/ blue-cross-blue-shield-companies-form-synergie-medication-collective-new-venture
5. The use of medicines in the U.S. 2022. IQVIA. April 21, 2022. Accessed February 6, 2024. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-use-of-medicines-in-the-us-2022
6. The use of medicines in the U.S. 2023. IQVIA. May 2, 2023. Accessed February 6, 2024. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-use-of-medicines-in-the-us-2023
7. Biosimilars: overview for health care professionals. FDA. Published online December 13, 2022. Accessed February 6, 2024. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals#What%20is%20a%20biosimilar%20 product
8. Biosimilars in the United States 2023–2027. IQVIA. Published January 31, 2023. Accessed February 6, 2024. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027
9. Biosimilar Product Information. FDA. Updated December 8, 2023. Accessed February 6, 2024. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
10. Stern AD, Chen JL, Ouellet M, et al. Biosimilars and follow-on products in the United States: adoption, prices, and users. Health Aff (Millwood). 2021;40(6):989- 999. doi:10.1377/hlthaff.2020.02239
11. Biosimilar Market Report, 4th Edition, Q1 2024. Biosimilar Market Dynamics. Samsung. December 2023. https://www.samsungbioepis.com/upload/attach/ SB+Biosimilar+Market+Report+Q1+2024.pdf
12. Purple book database of licensed biological products. FDA. Updated January 29, 2024. Accessed February 6, 2024. https://purplebooksearch.fda.gov/
13. Kocher RP, Adashi EY. A new approach to cancer bundled payments in Medicare—the enhancing oncology model. JAMA Health Forum. 2023;4(1):e224904. doi:10.1001/jamahealthforum.2022.4904
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