Specialty Pharmacy

ICER Examines Cost Effectiveness, Clinical Effectiveness of Multiple Sclerosis Drugs

Three FDA-approved multiple sclerosis treatments and one MS drug that the FDA is currently reviewing are not cost effective, according to an analysis from the Institute for Clinical and Economic Review (ICER). Jon Campbell, Ph.D., ICER’s senior vice president for health economics and one of the report’s authors, also tells AIS Health that there was “insufficient evidence” to differentiate the clinical effectiveness of any of those four drugs, which are known as monoclonal antibodies.

The findings were part of a larger ICER draft evidence report published on Oct. 17 that examined the clinical effectiveness and cost effectiveness of oral and monoclonal antibody disease modifying therapies (DMTs) for relapsing-remitting MS. About 85% of the 1 million Americans with MS have the relapsing-remitting form.

Novel Therapies Take Center Stage in Optum Rx Drug Pipeline Report

In its latest report highlighting notable drugs nearing FDA approval, UnitedHealth Group’s Optum Rx PBM singles out two therapies designated as orphan drugs and one that has been granted priority review. Experts tell AIS Health that payers deciding how to cover these drugs will undoubtedly have to weigh factors such as a high unmet need for treatment, the durability of patients’ response to the therapy, and potentially high price tags.

For example, regarding the only non-orphan drug included in the report, Apellis Pharmaceuticals, Inc.’s pegcetacoplan, there are currently no other approved treatments for the condition it’s targeting, “so that will have an impact on how payers approach coverage,” says Bill Dreitlein, senior director of Pipeline & Drug Surveillance at Optum Rx.

Specialty Pharmacy’s Dose Optimization Program Saved More Than $6 Million Last Year

As spending on specialty drugs continues to rise, payers are implementing various utilization management strategies in an effort to rein in their costs. While prior authorization and step therapy are perhaps the most common tactics, other approaches, such as quantity limits, site-of-care optimization and dose optimization also can be successful tools, as evidenced by one specialty pharmacy’s recent announcement.

In September, AllianceRx Walgreens Pharmacy revealed that its use of dose optimization resulted in $6.2 million in savings in 2021. The strategy reduces the number of dispensed units of an oral, injectable or infusible agent while delivering the same appropriate dose. Some manufacturers charge the same or similar price for different doses of a drug, so if a patient is given a prescription for two 10 mg tablets per day, and a 20 mg tablet is available, it can be more efficient and economical for the patient to take the single 20 mg tablet.

Questions Exist Around Some Alternate Funding Companies That Carve Out Specialty Drugs

With companies trying to keep their prescription drug spending down, some have turned to alternate funding companies. While their approaches may seem appealing initially, some — such as ones that carve out certain specialty drugs and seek coverage from patient assistance funds — may not be worth the investment, say industry sources, who encourage companies to take a closer look at what their savings actually are.

During a July 29 webinar titled Specialty Drugs Update: Trends, Controversies, and Outlook, longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, noted that while the use of copay accumulators and maximizers has risen, “there is another newer trend that’s even scarier, and that’s the business of what some people call specialty carve-outs,” he said, calling this “the shady business of specialty carve-outs.” Vendors such as ImpaxRX, Paydhealth, SHARx, PayerMatrix and Script Sourcing get payers to exclude specialty drugs and then get those drugs covered via patient assistance programs at manufacturers or charitable foundations. If patients are denied patient assistance, coverage reverts to the company’s payer/PBM/specialty pharmacy.

Walgreens’ Purchase of Remaining Shields Stake Signals Threat to Independent Specialty Pharmacy Landscape

After increasing its share in Shields Health Solutions last year, Walgreens Boots Alliance, Inc. has entered into an agreement to purchase the remaining stake of the health system-owned specialty pharmacy integrator. The move, says one industry expert, may represent one more step in putting independent specialty pharmacies out of business.

After making incremental investments in Shields, Walgreens said on Sept. 20 that it would purchase the remaining 30% stake for approximately $1.37 billion. Shields — which partners with health systems to help them create and grow a hospital-owned specialty pharmacy program — has served more than 1 million people and has almost 80 health system partners that represent nearly 1,000 hospitals across the U.S. Shields will operate as a separate business and brand within Walgreens.

Industry Experts Question Alternative Funding Companies That Carve Out Some Specialty Drugs, ‘Abuse’ Charities

As companies are exploring different strategies to keep their pharmaceutical costs in check, a spate of so-called alternate funding companies has emerged in the industry. And while they might appeal to a potential client at first glance, some — such as ones that carve out certain specialty drugs and seek coverage from patient assistance funds — may not be worth the investment, say some industry sources, who encourage companies to take a closer look at what their savings actually are.

During a July 29 webinar titled Specialty Drugs Update: Trends, Controversies, and Outlook, longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, noted that while the use of copay accumulators and maximizers has risen, “there is another newer trend that’s even scarier, and that’s the business of what some people call specialty carve-outs,” he said, calling this “the shady business of specialty carve-outs.” Vendors such as ImpaxRX, Payd Health, SHARx, PayerMatrix and Script Sourcing get payers to exclude specialty drugs and then get those drugs covered via patient-assistance programs at manufacturers or charitable foundations. If patients are denied patient assistance, coverage reverts to the company’s payer/PBM/specialty pharmacy.

Employers Shift More Drug Cost Control Efforts From PBMs to Medical Plans

In 2021, prescription drugs accounted for a median of 21% of large employers’ health care costs, and a full 100% of firms said they were concerned about prescription drug spending trends, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey.

Yet the rising cost of specialty medications — which are often covered by medical rather than pharmacy benefits — has forced companies to think differently about how to curtail drug spending, the organization found. According to the survey, specialty medications account for 56% of all pharmacy spending by polled employers.

Employers Shift More Drug Cost Control Efforts From PBMs to Medical Plans

In 2021, prescription drugs accounted for a median of 21% of large employers’ health care costs, and a full 100% of firms said they were concerned about prescription drug spending trends, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey.

Yet the rising cost of specialty medications — which are often covered by medical rather than pharmacy benefits — has forced companies to think differently about how to curtail drug spending, the organization found. According to the survey, specialty medications account for 56% of all pharmacy spending by polled employers.

FDA Approves Gene Therapy, Manufacturer Prices Drug at Record $2.8 Million

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.

Payers, Dermatologists Say They Are Interested in New Psoriasis Topicals Vtama, Zoryve

Two new drugs to treat plaque psoriasis are adding to the topical options available to treat the condition. Both payers and dermatologists have expressed interest in the agents, according to Zitter Insights, and the class remains a high priority for payer management.

On May 23, the FDA approved Roivant Sciences subsidiary Dermavant Sciences, Inc.’s Vtama (tapinarof) cream for the topical treatment of plaque psoriasis in adults, regardless of disease severity. The company said the agent is the first and only FDA-approved steroid-free topical medication in its class. Dosing of the aryl hydrocarbon receptor agonist is once daily on affected areas, and the drug has no restrictions on length of use. The price for one tube of the drug is $1,325.