This Week in Managed Care: July 26, 2019

Bipartisan Senate bills take aim at drug prices, especially insulin; a study links payer refusal to pay for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors with heart attacks and deaths; and a former FDA commissioner visits The American Journal of Managed Care^® (AJMC^®).

Welcome to This Week in Managed Care, I’m Jaime Rosenberg.

Senate Finance Committee Introduces Bill to Lower Drug Prices

Leaders of the Senate Finance Committee introduced bipartisan legislation this week to rein in prescription drug costs. Finance Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Oregon, said the Prescription Drug Pricing Reduction Act of 2019 will lower out-of-pocket costs for those on Medicare and Medicaid while saving the government billions.

A Congressional Budget Office estimate said the bill will trim $85 billion from Medicare Part D and $27 billion from out-of-pocket costs over 10 years. The bill would do the following:

• Eliminate the coverage gap
• Launch 25% cost sharing between the annual deductible and catastrophic threshold by 2022
• End cost sharing once beneficiaries reach catastrophic coverage, which could be $3100

For more, visit ajmc.com.

Senate Bill Would Roll Back Insulin Price Hikes

A separate bill introduced this week takes on the rising cost of insulin, a crisis that has taken center stage in hearings this year. A bipartisan group of senators led by Diabetes Caucus chairs Jeanne Shaheen, D-New Hampshire, and Susan Collins, R-Maine, said their legislation could cut insulin prices by up to 75%.

The bill takes aim at rebates that experts say drive up the cost of insulin, by barring insurers and pharmacy benefit mangers (PBMs) from engaging in rebate plans with insulin manufacturers who agree to roll back their prices to 2006 levels. The bill won support from JDRF and the American Diabetes Association.

Said Aaron Kowalski, PhD, president and chief executive officer of JDRF: “JDRF supports eliminating [rebates] and requiring insulin manufacturers to drop their prices, as this bill would do. At the same time people with diabetes need access to affordable insulin year around, and JDRF supports the bill’s provisions to cover insulin outside the deductible, to prevent spikes in costs at the beginning of the year.”

The bill come after witnesses told Congress about cases in which young adults with diabetes died after rationing insulin, and about traveling to Canada to buy cheaper insulin, and after manufacturers and PBMs blamed each other for the current pricing schemes.

For more, visit ajmc.com.

Rejected PCSK9 Prescriptions Linked to Cardiovascular Events

Insurers who refused to cover expensive new cholesterol drugs that reached the market in recent years put patients at higher risk of heart attacks, strokes, and early death, according to a study published this week.

Insurers frequently denied coverage for the therapeutic class called PCSK9 inhibitors in the years after they were approved in 2015. The drugs were approved for 2 conditions, familial hypercholesterolemia, an inherited condition known as FH, or atherosclerotic disease. Now, research in the journal Circulation: Cardiovascular Quality and Outcomes, published by the American Heart Association, finds patients were 16% more likely to have a cardiovascular event if their prescription was rejected than if it was covered and filled for approximately 1 year.

If the drug was covered but the patient did not fill it, the patients were 21% more likely to have a cardiovascular event.

Said Kelly Myers, BS, chief technology officer of the FH Foundation and lead study author, “We have both treatment guidelines and available medication to help reduce cholesterol and associated cardiovascular events in the most vulnerable high-risk patients, and yet barriers in the healthcare system—such as higher treatment costs, tight restrictions of approvals, Medicare rules against co-payment assistant, and lack of coverage—are delaying treatment.”

During the study, the drugs still came with a $14,000 annual price tag, but pushback from payers led to price cuts. The drugs now cost about $5850 per year. The findings align with a study in the current issue of AJMC^®, which shows that capping patient assistance for specialty drugs leads to significantly lower monthly fill rates and higher rates of discontinuation.

For that study, visit ajmc.com.

Riboflavin Consumption and Migraine Occurrence

One of our most popular stories this week concerns findings from the American Headache Society, which show that consuming riboflavin, better known as vitamin B2, may help reduce episodes of migraine. While supplements of B2 have been linked to reduced migraine, this study focused on gaining higher levels of the vitamin through food.

The abstract from the society’s annual meeting reported on survey results from 3600 adults with likely migraine status who took the National Health and Nutrition Examination Survey. B2 intake was calculated based on what the respondents recalled eating in the past 24 hours, along with whether they reported having a migraine or severe headache.

The researchers concluded: “Future migraine prophylaxis studies may consider reevaluating the effective riboflavin supplement dose and the influence of baseline dietary riboflavin intake on the symptoms of migraine.”

Gottlieb on Real-World Evidence, and More

Finally, this week former FDA Commissioner Dr Scott Gottlieb visited AJMC^® for an interview about his time at the agency, the future use of real-world evidence, and his view of the market for biosimilars. Dr Gottlieb discussed the potential impact of this week’s new Senate bill to reduce out of pocket costs for prescription drugs.

For all of us at the Managed Markets News Network, I’m Jaime Rosenberg. Thanks for joining us.