There is a gap in current formulary decision support tools: how to prepare for the annual avalanche of new drug approvals. The FDA approved 59 investigational drugs for distribution in 2018, beating the 2017 total of 46. The number of approvals in 2018 also sets a record for the number of new drug approvals in a single year. The previous highest annual total was 53 in 1996.
Almost 3/4 of the drugs (43) had priority reviews. Almost half of the priority reviews were filed as orphan drugs (34), while 58% were for rare diseases, 41% had Fast Track status and almost a quarter were designated as Breakthrough Therapies (14).
Tools are available that provide comparisons of available drug products. Such offerings may include a drug’s comparative efficacy, therapeutic role and class monographs to assist with drug therapy decisions. Clinicians can access services that detail the information, including access to past reviews, about recently released and investigational drugs. But with an average of between 3.8 and 5.9 new drugs approved every month, keeping up with their approval status is almost unviable. Additionally, current tools do not provide actionable intelligence about pending multiple drug approvals for the same indication, class or therapeutic category. For example, in 2018 three drugs were approved for migraine prophylaxis: Erenumab (Aimovig), Fremanezumab (Ajovy), and Galcanezumab (Emgality).
In May, upon the approval of erenumab we included the following advisory statement within the Pharmaceutical Pipeline Tracker’s monograph for the drug. The advisory statement was updated in the fall as ICER released a final version of its review and two additional drugs were approved.
“The FDA approved erenumab on 5/17/18 for the prevention of migraine. The drug will have an annual WAC price of $6,900. Monthly Sub-Q injection. Erenumab is available as a patient administered auto-injector. Lilly plans to offer an auto-injector for galcanezumab. Fremanezumab is a more viscous solution and will initially be offered as a prefilled syringe. So, while the drug may be approved as a quarterly subcutaneous injection, it may require a visit to a physician's office for administration, while monthly doses of galcanezumab and erenumab can be administered by the patient. Teva is working on an auto-injection system for fremanezumab, but it is not known when it will be available. Express Scripts is pushing CGRP inhibitor manufacturers to set a lower price for their drug, rather than set a high price and offer a rebate. Express Scripts also wants to set up performance contracts for the drugs based on efficacy on use of the drug in their patients. ICER released a final review of CGRP inhibitors on July 3, 2018. ICER found insufficient evidence to recommend erenumab or fremanezumab over oral preventative drugs or botulism toxin for prevention of migraine in untreated patients. ICER did find evidence of a benefit for use of erenumab or fremanezumab in patients that had previously failed preventative therapy for chronic migraine. Data was supportive but inconclusive for prevention of episodic migraine. ICER found insufficient evidence for use of galcabezumab in either indication. The drugs were found to be safe with the most common ADR of injection site reactions and upper respiratory symptoms. CGRP inhibitors were estimated to improve quality of life years (QALY) for episodic and chronic migraine patients. With an announced WAC price of $6,900/year for erenumab, ICER estimates an annual cost of $5,000/year after discounts. ICER estimated a price of $3,700 to $5,300 per year to be cost effective. Erenumab or fremanezumab were found to be cost effective in QALY gained in patients that had failed at least one preventative therapy. The estimated cost per QALY was lower for chronic migraine compared to episodic migraine. ICER felt that insurers would be justified in setting limits or restrictions on CGRP inhibitors due to insufficient long-term safety data and high cost.”
This was actionable intelligence upon which to weigh whether to wait for all three approvals before adding any of the new drugs to the formulary.
Alder Biopharmaceutials has submitted a BLA for eptinezumab. If approved, this will be the fourth member of the class. We are currently monitoring this drug and updating our advisory as new information becomes available. Eptinezumab will be dosed quarterly, but unlike the other drugs, it is administered by IV infusion.
Another gap in the current set of formulary decision support tools is the lack of ability to anticipate the timing of the introduction of budget busting drugs: those given priority review and/or priority designations. Only a select number of drugs are deemed eligible for priority review. Typically, those given priority represent significant medical breakthroughs or offer treatment where few or no other options exist. Priority review is often granted to drugs that aim to treat serious medical conditions. Between March and the end of September 2019, there are eighteen investigational drugs with PDUFA Dates. Two of those drugs were added to the list just this month. The FDA approved Caplacizumab with orphan drug priority designation on its February 6, 2019 PDUFA date for the treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP). It was and is the only investigational drug targeted to treat the indication.
In a recent editorial, Marilyn Speedie, dean emeritus, University of Minnesota College of Pharmacy explored the widespread agreement about the importance of controlling prescription drug costs. She stated that one extremely important piece of the solution is to fully enlist pharmacists in optimizing the use of the medications the public and health plans are paying for. Being prepared for the release of expensive new drugs, their benefit and their challenges can help control the cost of drug therapy, so the right drug is used in the right patient at the right time.
Let’s get together and discuss how the Pharmaceutical Pipeline Tracker can fill the current gap in your formulary decision support suite.
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