Payers to pharma: Here’s what we’re missing in hep C drugs

Payers have unmet needs in the changing hepatitis C (HCV) space, according to a new survey.

The survey, from Precision for Value, highlights what can be done in order to encourage payers to ease coverage policies for these drugs in the next wave of HCV treatment.

Schafer

“Payer priorities are shifting to wanting agents that address difficult to treat HCV patients including those with less common genotypes and patients failing prior therapy,” says Jeremy Schafer, PharmD, MBA, senior vice president, director specialty solutions at Precision for Value.

The unmet needs cited by payers in the survey included addressing prior treatment failures (64%), overcoming resistance (52%), shortening the duration of therapy (40%). To ease coverage, payers need two things: reduced costs and proven outcomes. 

Real-world outcomes a must

The survey found that 48% of payers wanted to see a real-world outcomes study. “Payers really want to see if the real-world outcomes have approached the clinical trials,” according to Schafer. “Payers spend significant money on HCV treatments but may lack the other side of the story, what are they getting? Are patients staying adherent? Are they being cured? If so, does the cure rate match what was seen in clinical trials? Answering these questions for payers may make them more comfortable with broader coverage. Unlike some other specialty disease states, HCV presents a specialty category where the outcome is well defined and trackable.”

Payers could partner with health systems or even specialty pharmacies to obtain information on cure rates or need for retreatment, Schafer advises. Manufacturers could also play a role by conducting real-world outcome studies to track the cure rates of patients treated on their product(s).

Cost will continue to be an issue as well, according to the survey.  More than two-thirds of payers saying current rebate is an integral factor when determining whether to switch a preferred therapy. In fact, nearly half of payers believed that if a product wanted to displace the current preferred agent, the net cost savings of the new product would need to be at least 30%.

“Even as utilization has plateaued or dropped, payers are guarded because HCV continues to be a cost driver,” Schafer says. “Aggressive contracting with an outcomes component where appropriate, may ease access as well. Now that the category has matured, more payers want to see pharma back up their claims with outcomes data and even outcomes based contracts.”

HCV continues to be a prevalent disease with only a fraction of the 2.7 to 3.9 million infected patients in the United States having received therapy, according to Schafer. The CDC recommends testing for all Americans born between 1945 and 1965 meaning that there could still be many patients waiting for therapy.

Next: Sovaldi's impact on the market

When Sovaldi hit the market, the surge in utilization was unprecedented, according to Schafer. “Coupled with the high-cost of a course of therapy, payers saw significant impact on their spend,” he says. “Payers rely on accurate forecasting of spend to set premiums and be competitive and the HCV surge devastated many of those projections. Since then payers have been cautious in HCV by contracting aggressively and implementing prior authorization criteria that was more strict than label in certain cases. Newer entrants by players like Merck have sought to address cost concerns by coming in with significantly lower prices but the relative high cost of therapy combined with high prevalence of HCV means payers are staying on guard.”

The HCV pipeline is rich and continues to produce new products as well with some being pangenotypic (drugs that work against every genotype), according to Schafer. “More competition creates more opportunity for payers to lower cost. While contracts help to offset pricing pressures, managing the budget remains challenging when looking at the total HCV population,” he says. “However, treating broader patient populations has benefit to payers as well through reduced end-stage liver complications and lower risk of HCV being spread to other individuals.”

Clinical outcomes

The survey results showed that payers are satisfied with the clinical efficacy of the current leading agents.

“The concerns around taking multiple agents with poor tolerability were removed by the newest therapies,” Schafer says. “Now that payers have single agents that can cure disease in a short duration, they are looking for pharma to fill gaps not addressed by current agents. Additionally, payers are even more focused on cost as the cure rates between therapies are so similar.”

The survey also showed provider acceptance of a different preferred product was important to 40% of payer respondents, indicating that provider opinion is important.

“This is an interesting finding as providers have come to understand and accept the preferred product placement and utilization management strategies deployed in the HCV space,” Schafer says. “However, their acceptance of the strategy still weighs heavily with payers. Balancing the financial needs of the payer with the prescribing preferences of providers and the tactics of the pharma sales teams will continue to be a dynamic process.”

Eighty-four percent of payers in the survey were interested in an outcomes or risk-based agreement. However, outcomes contracts are tricky and require two important components: a defined outcome and the ability to track the outcome, according to Schafer.

“For HCV, the first is simple, whether the patient achieved a cure.  The second is more complicated,” he says. “Payers will be able to see in their claims data that a patient was treated but generally won’t be able to see if the patient is cured. However, integrated delivery systems with a payer component may be able to execute such an agreement due to the connection between the in house payer and the health system holding the patient lab data.”

For payers without a health system connection, outcomes contracts based on patient adherence or completing the entire course of therapy may be more realistic than a contract based on cure rates, he says.

“Payers seeking to execute an outcomes based agreement should first review their own capabilities to determine what is reasonable but also look for partnerships, including with a specialty pharmacy, to see if these partnerships expand the payer’s options for an outcomes based agreement,” Schafer says.