Market access

MMIT Reality Check on Anemia Due to Chronic Kidney Disease

A review of market access for treatments for adults with anemia due to chronic kidney disease shows that under the pharmacy benefit, about 37% of the lives under commercial formularies are covered with utilization management restrictions. Around 41% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Specialty Pharma Payer Deals Point to Outsourcing Trend

As prices for specialty pharmacy products continue to soar, payers are looking for new ways to gain more control over the distribution of expensive, often-provider-administered drugs. Last week, Kaiser Permanente and Highmark Blue Cross Blue Shield both struck deals aimed at managing specialty pharmacy spend — and one expert says that more deals like them are coming, especially from Kaiser’s new business partner, Cigna Corp. subsidiary Evernorth.

Kaiser Permanante (KP), the multistate integrated payer-provider based in California, doesn’t enter agreements with service providers outside its self-contained system very often. That said, Kaiser Permanente spokesperson Stephen Shivinsky tells AIS Health that “Kaiser Permanente and Accredo” — the specialty pharmacy division of Evernorth — “have had an existing relationship, which will expand further under part of this new agreement.”

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News Briefs: Humana Wins in Rite Aid Reimbursement Dispute

AllianceRx Walgreens Prime — a specialty and home delivery pharmacy business owned by Walgreens Boots Alliance — is rebranding to AllianceRx Walgreens Pharmacy. The move comes after Walgreens assumed full ownership of the business; previously, it was a joint venture between Walgreens and the PBM Prime Therapeutics. In addition to the company’s name change, it promoted Tracey James, R.Ph., from the role of senior vice president to chief operating officer.

Rite Aid Corp. must pay Humana Inc. $123 million after an arbitrator found that the retail pharmacy chain inflated reimbursement claims above the “usual and customary” prices for drugs, Stat reported. Rite Aid’s rival Walgreens Boots Alliance Inc. faces a similar lawsuit brought by several Blue Cross and Blue Shield affiliates. In both cases, the payers allege that the pharmacy chain systematically charged the health plans inflated prices for generic prescription fills. The health plans claim that their contracts with the pharmacies entitled them to reimburse the pharmacies for drug fills at the lowest price that the pharmacies charged for the drug in question, an arrangement called “usual and customary” pricing. However, the health plans say that the pharmacies charged cash-paying customers less than the “usual and customary” price submitted to health plans for reimbursement. Rite Aid plans to ask a federal court to vacate the arbitrator’s decision in the Humana case, per Stat, while the Walgreens-Blues suit is pending.

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MMIT Reality Check on Growth Hormone Deficiency

A review of market access for treatments for adults with growth hormone deficiency shows that under the pharmacy benefit, about 52% of the lives under commercial formularies are covered with utilization management restrictions. Around 59% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Many Medicare Enrollees Can’t Afford Cancer, Specialty Drugs

Large numbers of Medicare beneficiaries who are ineligible for low-income subsidies and have been prescribed high-price prescription drugs for conditions such as cancer don’t initiate their treatment, likely because they can’t afford it, according to new research published in Health Affairs. One of the study’s authors tells AIS Health that severe illness is a possible outcome of noninitiation in the studied clinical areas and adds that proposals under consideration in Congress to cap out-of-pocket spending for Medicare beneficiaries would make a big difference to the affected patients.

According to the paper, “among beneficiaries without subsidies, we observed noninitiation for 30 percent of prescriptions written for anticancer drugs, 22 percent for hepatitis C treatments, and more than 50 percent for disease-modifying therapies for either immune system disorders or hypercholesterolemia.”

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MMIT Reality Check on Seizure Emergency

A review of market access for seizure emergency treatments shows that under the pharmacy benefit, about 35% of the lives under commercial formularies are covered with utilization management restrictions. Around 17% of the lives under health exchange formularies are not covered for at least one of the drugs.

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Payers Applaud as CMS Stands Ground on Aduhelm Coverage

In a move derided by some health care stakeholders and applauded by others — including private payers — CMS on April 7 finalized its National Coverage Determination (NCD) for an Alzheimer’s treatment that has been steeped in controversy since it received accelerated approval last June.

The final coverage decision largely affirmed what CMS had proposed in its draft NCD: Medicare will cover Biogen Inc.’s Aduhelm (aducanumab) only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. Patients also must have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain.

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Many Medicare Enrollees Can’t Afford Cancer, Specialty Drugs

Large numbers of Medicare beneficiaries who are ineligible for low-income subsidies and have been prescribed high-price prescription drugs for conditions such as cancer don’t initiate their treatment, likely because they can’t afford it, according to new research published in Health Affairs. One of the study’s authors tells AIS Health that severe illness is a possible outcome of noninitiation in the studied clinical areas and adds that proposals under consideration in Congress to cap out-of-pocket spending for Medicare beneficiaries would make a big difference to the affected patients.

According to the paper, “among beneficiaries without subsidies, we observed noninitiation for 30 percent of prescriptions written for anticancer drugs, 22 percent for hepatitis C treatments, and more than 50 percent for disease-modifying therapies for either immune system disorders or hypercholesterolemia.”

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MMIT Reality Check on Acute Myeloid Leukemia

A review of market access for treatments of adults with acute myeloid leukemia (AML) shows that under the pharmacy benefit, about 68% of the lives under commercial formularies are covered with utilization management restrictions. Around 7% of the lives under Medicare formularies are not covered for at least one of the drugs.

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After Aduhelm, Congress May Revamp Accelerated Approvals

The FDA’s accelerated approval of Alzheimer’s drug Aduhelm (aducanumab) last year was extremely controversial, prompting harsh criticism and calls for reform of the accelerated approval process itself. Congress has taken up the issue and is considering one bill from each major party that would revamp the process in the hope of addressing concerns that the pathway has allowed flawed drugs to stay on the market without being revisited.

Medical research and health care policy experts have raised a number of critiques of the current accelerated approval framework. Two critiques stand out: The first concerns the quality of data used in measuring the effectiveness of accelerated approval drugs. After a drug is granted accelerated approval, the FDA mandates that the drug be evaluated using confirmatory clinical trials. Experts have criticized the quality of data collected for accelerated approval drugs; in particular, the measurements used to gain approval for Aduhelm were heavily criticized by clinicians.

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