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Specialty Pharmacy Pipeline | Drugs to Watch
Anticipated Launches | Q4 2017–Q1 2018
The market for migraine medications is ripe for growth due to a large patient population with an unmet clinical need. Current abortive treatments don’t work for all patients, and many preventive treatments have tolerance challenges.
Four investigational medications from a new drug class known as calcitonin gene-related peptide (CGRP) inhibitors will dominate the pipeline over the next two years, and they are expected to generate significant spending growth. CGRP is a substance that helps neurons communicate with each other. For reasons as yet unknown, CGRP levels increase in patients during a migraine. The drugs in development work by binding to CGRP itself or blocking its receptor. In clinical trials, CGRP inhibitors have been shown to be effective as a prophylactic treatment to help prevent migraines. If approved, these will be the first medications that were specifically developed with migraine prevention as the primary indication. Although current prophylactic and acute treatments help many people with migraine, they are far from perfect and better treatments are needed.
The Migraine Landscape
Migraine cost Americans an estimated $36 billion annually in lost productivity and health care expenses.
More than 39 million Americans suffer from migraine, a debilitating neurological condition characterized by intense headaches. Other common symptoms of migraine are sensitivity to light or sound, vomiting, and vision changes, such as blurred vision. The causes of migraine are unknown and there is no cure.
Migraine symptoms vary significantly from patient to patient. For instance, some patients see an aura and others don’t, some experience nausea or vomiting, while others never do. Neurologists generally categorize migraine as episodic or chronic. Episodic migraine is defined as having up to 14 headache days per month, while chronic migraine is defined as having headaches 15 or more days per month.
Migraine pain can be serious and even incapacitating. Migraine is the sixth most disabling illness in the world as measured by years lost due to disability. Every 10 seconds, someone in the U.S. goes to the emergency room complaining of head pain, and approximately 1.2 million visits are for acute migraine attacks.
History of Treatment
Currently, a wide range of medications, originally developed for other indications, are used to treat and prevent migraine. Medications prescribed as preventives include anti-hypertensives, Botox, antidepressants, and anticonvulsants. While these drugs work well for some patients, they don’t for many others, and patients can also experience issues with tolerance. Many of them cause a range of side effects, such as fatigue, dizziness, and weight gain, which can result in patients discontinuing therapy.
Once migraine symptoms start, a different list of drugs is recommended to stop the symptoms, including triptans, analgesics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Triptans, which became available in the 1990s, provide relief for many migraine sufferers, but they shouldn’t be taken by people with certain cardiovascular diseases or uncontrolled hypertension.
Four Pipeline Drugs
The four CGRP inhibitors in development are prophylactics that would all require either monthly or quarterly subcutaneous or intravenous (IV) administration. So far in clinical trials, all four appear to reduce headache frequency and have a reasonable safety profile. Compared to placebo, the drugs reduced headache days by an additional one to two days per month. The drugs are in development for the prevention of both chronic and episodic migraines.
- Erenumab has shown to be effective in reducing headaches for those who suffer from both chronic and episodic migraine. Erenumab is pending U.S. Food and Drug Administration approval and could be available in mid-2018.
- Galcanezumab garnered positive Phase 3 results as a prophylactic for both episodic and chronic migraine.
- Fremanezumab has produced positive Phase 3 results with both monthly and quarterly subcutaneous injections, for people with chronic and episodic migraine.
- Eptinezumab, a fourth agent, is further out in the development pipeline but delivered positive Phase 3 results for people with episodic migraine. The drug would be administered quarterly as an IV infusion.
Cost Management Considerations
Source: CVS Health Medical Affairs Pipeline Services, 2017.
There is still much to be learned about these drugs in terms of their effectiveness and safety profiles for various patients – and whether efficacy depends on types of symptoms, frequency, or duration of symptoms. It’s important to ensure that patients have access to the most clinically appropriate medications and that payors have the right cost management tools in place to address the impact on trend.
That’s why we constantly monitor the pipeline and proactively develop and implement strategic cost management tools. Prior to launch, we seek input from external thought leaders so that we can model potential impact. We also have dedicated resources including experienced clinicians who closely follow and evaluate the drug pipeline to determine appropriate formulary placement and potential designation as a specialty drug. At launch, new-to-market review and an assessment of clinical appropriateness inform strategic plan design options, such as utilization management, including use of prior authorization, formulary management, such as tiered placement, and step therapy requirements. Ensuring the right patient gets the appropriate drug at the right time can help balance cost for payors and access for plan members.
Source: CVS Health Medical Affairs Pipeline Services, 2017.
Source: CVS Health Internal Analysis, except where noted.
The information contained herein is compiled from independent clinical sources and is provided for informational purposes only. Due to circumstances beyond CVS Caremark’s control, prospective drug launch dates are subject to change without notice.
This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.
Image source: Licensed from Getty Images, 2017.
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