Formulary

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Six biologics are on the market and more are in the pipeline. Biologics target the inflammatory cytokines involved in the pathogenesis of asthma.

Dogged by controversy, the new Alzheimer’s drug has not fared well since its approval by the FDA a year ago.

Amgen’s biologic won’t have biosimilar competition till 2029. But the possibility that up to 11 Humira biosimilars may come on the market in 2023 could exert some downward pressure on Enbrel’s price.

Last month, the Centers for Disease Control and Prevention shared a draft update to its Clinical Practice Guideline for Prescribing Opioids. The proposed revision comes as the nation’s overdose death rate reaches an all-time high, fueled largely by the economic and psychological strains and lack of healthcare access caused by COVID-19.

EmsanaRx, a pharmacy benefit manager launched by the Purchaser Business Group on Health, started operations in January.

ICER’s first scorecard of the barriers to fair access to medications found, of the policies that could be reviewed, most were structured to support fair access to medications.

Copays and formulary tiers involve financial incentives to use certain drugs. But is Cigna’s offer of a $500 debit card in a different category?

FDA approval of Lumakras was contingent on a trial testing lower doses. It could usher in a new era of optimal dosing instead of the maximum tolerated dosing.

Low prices and some gaming of regulations can drive out competitors and create monopolies that allow generic makers to jack up their prices. Experience has shown that it often takes multiple generics to achieve the promised-for downward pressure on prices.

The biggest price increase was a 9.5% rise for Zogenix’s Fintepla (fenfluramine), used to treat seizures associated with Dravet syndrome.

Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.

A new indication, a nonprescription switch, a recall, and new guidances round out this week’s FDA news.

Ten years ago, specialty accounted for 15% to 20% of the money spent on drugs, according to Prem Shah, executive vice president of specialty pharmacy and product innovation at CVS Health.

PBMs say exclusions are important for negotiating lower prices on behalf of health plans and members. Some payer and provider groups say they interfere with patient access to medicines.

As hearings of the FDA panel have shown, once a drug is approved and in clinical guidelines, pulling it from the market is not so simple, even if later trials do not confirm phase 2 results.

Having specialty pharmacies fill prescriptions may lower costs, but critics of the practice see safety issues and other drawbacks.

Drug and diagnostic approvals and biosimilars news were popular with readers.

How the pandemic has accelerated innovation, and how CVS Health is preparing to delivery vaccines for COVID-19.

The second mRNA vaccine, which does not need the extreme refrigeration of the Pfizer product, began rolling out of a warehouse in Mississippi early Sunday. Friday brought other late-year approvals in cancer treatment.

Pfizer's other vaccine news of the week involves pneumococcal disease.

As the world remains battling the coronavirus pandemic, there are still significant and unmet needs for those fighting chronic conditions and disorders like opioid use disorder (OUD).

FDA approves several drugs to treat rare conditions in both cancer and metabolic diseases.

Health plans build strategies to ensure their beneficiaries have easy access to and receive vital immunizations.

If Pfizer's vaccine gets an emergency use authorization, it could reach sites designated by states within a day.

Manufacturing issue creates setback for Alkermes on much-anticipated therapy that mitigates weight gain.

Gilead's Veklury gets full approval; AstraZeneca's Tagrisso heads toward second indication in NSCLC; another use for experimental antifungal therapy.

The PDUFA date for Alkermes' combination therapy is November 15, 2020.

Can data mined from EHRs match that from the gold standard, randomized clinical trials?

Approval for treatment of HES, update to address addictive nature of benzodiazepines.