Radar on Drug Benefits

After the FDA approved Zynteglo (betibeglogene autotemcel) on Aug. 17, the gene therapy’s manufacturer, bluebird bio, Inc., announced the drug would have a $2.8 million wholesale acquisition cost (WAC). That is the highest WAC for a drug hitting the market in the U.S.

Zynteglo is indicated as a potential cure for patients with transfusion-dependent beta-thalassemia, a rare disorder caused by genetic mutations in cells that carry oxygen throughout the body. Such patients typically require red blood cell transfusions every two to five weeks.

More than 1.4 million Medicare beneficiaries could see their medication costs plunge if the Senate passes a budget reconciliation bill that contains drug pricing reforms, Kaiser Family Foundation estimated.

The bill — put forward by Senate Majority Leader Chuck Schumer (D-N.Y.) and Sen. Joe Manchin III (D-W.Va.) — will allow Medicare to negotiate some prescription drug prices starting in 2026 and require drug companies to pay rebates if drug prices rise faster than inflation starting in 2023. Between 2019 and 2020, half of drugs covered by Medicare Part D and 48% of drugs covered by Medicare Part B saw price increases greater than the rate of inflation (1.0%), according to a previous Kaiser Family Foundation analysis.

Unlike in recent periods, PBMs were not necessarily stars of the show as the country’s largest publicly traded managed care organizations reported their second-quarter 2022 earnings. However, executives across the board still touted PBMs as a key component of their growth and diversification strategies.

At UnitedHealth Group, the first major MCO to report its quarterly results, one equities analyst queried the health care giant’s leaders about why OptumRx’s “strong” revenue and membership growth haven’t translated into larger margins.

Although Congress is on the brink of passing a landmark prescription drug price reform bill as part of the Inflation Reduction Act (IRA) — Democratic leadership in the House of Representatives plans to vote on the bill Friday — the legislation will not include any provisions that impose price controls on insulin sold to patients with commercial insurance. D.C. insiders tell AIS Health, a division of MMIT, that they do not expect separate, standalone legislation to make it through Congress any time soon, which shines a spotlight on new insulin benefits announced by major carriers like UnitedHealth Group.

A U.S. appeals court ruled that AbbVie Inc. does not need to defend itself from a lawsuit brought by the city of Baltimore, unions and insurance carriers that alleges the pharma giant used a patent thicket to improperly protect Humira (adalimumab) from competition. Before the ruling, the suit had the potential to upend widespread pharma industry business practices if it had been decided against AbbVie. It also comes amid news that the Biden administration is launching efforts to prevent patent thicketing, a process by which pharmaceutical companies extend patent exclusivity beyond what patent law ostensibly allows. Two laws, the Hatch-Waxman Act and Orphan Drug Act, set typical patent windows at five years and seven years, respectively. High-level officials at the FDA and the U.S. Patent and Trademark Office in July said they would be working together to scrutinize certain practices that could potentially lead to delays in competition from biosimilars and generics.

As soon as Friday, Congress is expected to pass Medicare prescription drug price reforms as part of the Inflation Reduction Act (IRA). The reforms are less ambitious than previous versions of drug pricing legislation considered by the current Congress, but various experts and health care stakeholders are mounting vehement arguments about the reforms’ ultimate impact on prices.

Under the bill, HHS would be able to negotiate the price of a gradually increasing number of drugs starting in 2026, when 10 drugs will be eligible for negotiation. The bill would also limit out-of-pocket drug costs for Medicare Advantage and Part D beneficiaries to $2,000 per year, and repeal the so-called rebate rule in Medicare Part D. In addition, the proposal would bar Medicare Part B and Part D drug prices from growing faster than inflation. In a summary of the late version of the reconciliation bill, Senate Democrats estimated that the drug pricing reform program would save $288 billion over 10 years.

In its latest drug pipeline report, UnitedHealth Group-owned PBM Optum Rx takes a look at two high-priced gene therapies that are slated for FDA approval soon. But those are far from the only gene therapies that payers should be watching, an Optum Rx executive tells AIS Health.

Both drugs highlighted in Optum’s report, Zynteglo (betibeglogene autotemcel) and Skysona (elivaldogene autotemcel), are manufactured by bluebird bio, Inc., a Massachusetts-based biotech company. An FDA advisory panel in June recommended both drugs for approval. Currently, only two gene therapies are on the U.S. market: Luxturna and Zolgensma.

CivicaScript last week began selling its initial generic drug, a 250 mg abiraterone acetate tablet. It’s the first of what the health insurer- and PBM-backed nonprofit company hopes are many medications that it will produce to help patients and payers lower their drug spending.

The product is currently only available through Intermountain Healthcare, a Utah-based integrated health plan and system that owns a specialty pharmacy, and Lumicera Health Services, a specialty pharmacy owned by Navitus Health Solutions. But CivicaScript President Gina Guinasso tells AIS Health, a division of MMIT, that she expects other pharmacies to offer the medication in the coming months.

Spending in the U.S. on medicines increased by 12% in 2021, primarily because of COVID-19 vaccines and therapies, according to the IQVIA Institute’s annual report on drug trends. The report also found that “Despite an increase in overall spending, costs per prescription on average are flat or slightly declining. Prescription drug use reached a record 194Bn daily doses in 2021 as new prescription starts for both chronic and acute care recovered from the slowdown recorded in 2020…[but] spending on medicines is expected to return to pre-pandemic growth trend lines by 2023.”

A federal appeals court on July 25 held that a Pfizer Inc. coupon program violated the federal Anti-Kickback Statute. The Second Circuit Court of Appeals ruled that Pfizer offering copay assistance to Medicare beneficiaries was illegal under the statue. AHIP applauded the ruling, arguing that “By upholding these protections, the courts have taken an important step to protect Americans from what would otherwise be an unchecked multi-billion-dollar price tag that would make coverage and care less affordable for everyone.”

UnitedHealth Group announced on July 15 that it would eliminate out-of-pocket costs for insulin and a few other medications for beneficiaries enrolled in fully insured plans. The managed care organization expects to implement the changes starting as early as Jan. 1, 2023, pending regulatory approval.

Health and drug policy experts who spoke with AIS Health, a division of MMIT, applauded UnitedHealth’s decision, and noted it would benefit patients who struggle to pay for medications and increase adherence. They also said the move could help United financially, as members are more likely to stay out of the hospital and have better long-term health, but they said it could lead to higher premiums for employers and employees. UnitedHealth did not respond to AIS Health’s request for comment on how the company would foot the bill for implementing the zero cost-share policy.