Radar on Drug Benefits

Despite New Approvals, Plans Still Favor Generics for Epilepsy

January 4, 2021

Pharmaceutical treatment for different types of epilepsy generally still relies on tried-and-true generics, despite recent efforts by drug manufacturers to introduce new branded medications into the mix, PBM insiders say.

Xcopri (cenobamate tablets), manufactured by SK Biopharmaceuticals Co., Ltd.’s subsidiary SK Life Science, Inc., launched in May for the treatment of partial-onset seizures. However, many plans haven’t jumped to add Xcopri to their formularies, says Mesfin Tegenu, R.Ph., president of PerformRx.

By Jane Anderson

Pharmaceutical treatment for different types of epilepsy generally still relies on tried-and-true generics, despite recent efforts by drug manufacturers to introduce new branded medications into the mix, PBM insiders say.

Xcopri (cenobamate tablets), manufactured by SK Biopharmaceuticals Co., Ltd.’s subsidiary SK Life Science, Inc., launched in May for the treatment of partial-onset seizures. However, many plans haven’t jumped to add Xcopri to their formularies, says Mesfin Tegenu, R.Ph., president of PerformRx.

“Some plans have opted to take a cautious approach and leave the medication as non-formulary to start,” Tegenu says. “It is difficult to tell the impact of this new drug launch on the treatment of epilepsy. However, Xcopri trials demonstrated high efficacy in partial onset seizures and refractory epilepsy, lending it a strong clinical profile. One could reasonably suspect a high impact on the epilepsy treatment paradigm.”

In most cases, though, generics are the first-line treatments for many forms of the disorder, according to Tegenu. Many of the drugs used to treat epilepsy are covered without restriction by plans.

Prime Therapeutics LLC treats Xcopri as a non-preferred brand, says April Kunze, senior director of clinical formulary development and trend management strategy for the PBM. Premera Blue Cross’ Medicare Advantage formularies, Cigna Corp.’s national preferred formulary and HealthPartners’ commercial formularies impose quantity limits on Xcopri, according to their plan documents.

“Treatment is based on the type of epilepsy diagnosed, and labeled and off-label indications of the individual products. There is a fair amount of overlap as many drugs share multiple indications. However, many newer agents are narrowly indicated,” Tegenu says.

In November 2018, GW Pharmaceuticals launched its product Epidiolex (cannabidiol), a much-anticipated new drug for two rare forms of childhood epilepsy. In August, the FDA expanded indications for Epidiolex to include seizures associated with tuberous sclerosis complex in patients age 1 or older.

“Based on previous positive trial results in TSC patients, Epidiolex may become an important treatment option for patients,” Elizabeth Thiele, M.D., Ph.D., director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, said in a statement when the FDA widened Epidiolex indications.

For his part, Tegenu expresses some skepticism about the drug. “Epidiolex represents another option for treatment of Lennox-Gastaut and Dravet syndrome,” Tegenu says. “However, its efficacy hasn’t shown significant improvement relative to existing treatments.”

2020 in Review: PBMs Continue Integration, Face More Regulatory Challenges

December 28, 2020

In 2020, the PBM industry continued to deepen its integration with other industry players, a trend that experts say is likely to continue in coming years. The PBM space has consolidated to the point that five firms — UnitedHealth Group’s OptumRx, CVS Health Corp.’s Caremark, Cigna Corp.’s Express Scripts, Anthem Inc.’s IngenioRx, Humana Inc.’s Humana Pharmacy Solutions, and the Blue Cross and Blue Shield affiliate-owned Prime Therapeutics LLC — manage the lion’s share of the pharmacy benefits offered to U.S. health plan members.

Beyond their deepening integration with the payers that own them, these firms are working to expand their data and direct-to-consumer operations.

By Peter Johnson

In 2020, the PBM industry continued to deepen its integration with other industry players, a trend that experts say is likely to continue in coming years. The PBM space has consolidated to the point that five firms — UnitedHealth Group’s OptumRx, CVS Health Corp.’s Caremark, Cigna Corp.’s Express Scripts, Anthem Inc.’s IngenioRx, Humana Inc.’s Humana Pharmacy Solutions, and the Blue Cross and Blue Shield affiliate-owned Prime Therapeutics LLC — manage the lion’s share of the pharmacy benefits offered to U.S. health plan members.

Beyond their deepening integration with the payers that own them, these firms are working to expand their data and direct-to-consumer operations.

Ashraf Shehata, national sector leader for health care and life sciences at KPMG, says that a “back to basics” approach for 2021 will be essential for PBMs, especially as their health plan owners navigate the uncertainty generated by the COVID-19 pandemic. However, he notes that the space is still managing the aftereffects of transactions and is looking for more deal-making opportunities.

In that realm, the long-term integration of Express Scripts into Cigna has generated the most noise. Under Cigna, Express Scripts has deepened a horizontal relationship with Prime Therapeutics.

Meanwhile, in November, Amazon.com Inc. made a big splash by unveiling new pharmacy services, including a prescription-discount service for uninsured individuals that taps into Express Scripts’ price-negotiation powers with manufacturers.

Midwestern supermarket chain Hy-Vee, Inc. also launched a PBM in December, while in March, Costco Wholesale Corp. purchased a minority stake in Navitus Health Solutions, a subsidiary of integrated health system SSM Health.

Shehata says that PBMs’ data expertise will be a key line of business going forward, especially as regulators and the new Democratic administration increase scrutiny on the industry.

He suggests that PBMs could expand beyond the traditional role into something more like a data and analytics clearinghouse for the entire health care industry and PBMs need to be aggressive in delivering value directly to consumers as regulatory scrutiny on the industry increases.

“Big data and [artificial intelligence is] going to sit in kind of the combination of the traditional PBM, …the more traditional health claim, and… detailed EHR data,” Shehata explains. “You’ll start to see a whole generation of organizations also bring in EHR data, because it’s much more accessible now.”

New-to-Market Oral Drugs May Not Always Have a Leg Up on Injectables

December 17, 2020

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

By Leslie Small

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they’re approved by the FDA. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

Take roxadustat, which if approved would be the first novel therapy for chronic kidney disease-related anemia since 1989 and would offer an oral alternative to the injectable erythropoiesis-stimulating agents (ESAs) currently being used to treat the condition.

“Dialysis-dependent patients usually get their ESAs administered with dialysis via IV infusion, so the oral alternative in these patients doesn’t provide a convenience benefit necessarily,” says Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx. “However, there may be alternative benefits around safety.”

Then there’s Orladeyo (berotralstat), BioCryst Pharmaceuticals, Inc.’s treatment for hereditary angioedema (HAE) attacks. When the FDA approved Orladeyo on Dec. 3, it became the first oral plasma kallikrein inhibitor for the prevention of HAE attacks, Dreitlein says.

“The convenience benefit for berotralstat would have been more significant,” he says, but the 2018 approval of approval of Takhzyro, which is subcutaneously administered every two to four weeks and can be self-administered, “diminishes that because it already reduced the number of injections vs. older C1 concentrate products.”

The FDA is expected to decide on Dec. 20 whether to approve relugolix, which would be the first oral GnRH receptor antagonist on the market for advanced prostate cancer.

Relugolix’s oral administration gives it an advantage over Firmagon (degarelix), which requires monthly subcutaneous injections by a health care provider “and hasn’t garnered much commercial success because of the frequent injections and injection site reactions,” Dreitlein says.

The more common GnRH receptor agonists, on the other hand, require intramuscular injections at intervals ranging from one to six months. “Compared to these drugs, relugolix might confer some clinical advantages, but the convenience benefit is reduced because you are replacing an injection given potentially every six months with an oral daily medication,” Dreitlein adds.

Rebate Reform May Be an Opportunity for Hy-Vee’s New PBM

December 14, 2020

Midwestern supermarket chain Hy-Vee, Inc. launched a new PBM subsidiary on Dec. 3, joining the already-crowded ranks of retail stores that have done the same. Industry consultants tell AIS Health that while Hy-Vee’s new PBM may struggle to compete with large and well-established players, there are ways it can still appeal to employers that are dissatisfied with the status quo in pharmacy benefits management.

“Starting a PBM today is risky, because the pharmacy benefits market is dominated by a few very large, sophisticated and insurance-integrated PBMs,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates.

By Leslie Small

Midwestern supermarket chain Hy-Vee, Inc. launched a new PBM subsidiary on Dec. 3, joining the already-crowded ranks of retail stores that have done the same. Industry consultants tell AIS Health that while Hy-Vee’s new PBM may struggle to compete with large and well-established players, there are ways it can still appeal to employers that are dissatisfied with the status quo in pharmacy benefits management.

“Starting a PBM today is risky, because the pharmacy benefits market is dominated by a few very large, sophisticated and insurance-integrated PBMs,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates.

However, “there are factors which suggest that there may be an opportunity for an initiative like Hy-Vee’s,” Rubinstein adds. One of those factors, according to Rubinstein, “is payers’ perennial dissatisfaction with their large PBMs.” In addition, he points to the recently revived rule that will eliminate the safe harbor for Medicare Part D rebates under the Anti-Kickback Statute and create a new safe harbor for rebates at the point of sale.

“The reason that this matters for a Hy-Vee PBM startup is that elimination of PBM rebates reduces PBMs’ power to move drug market share via formulary placement and prior authorization policies — thereby somewhat leveling the playing field between the largest and smaller PBMs,” Rubinstein says. “At the same time, 100% application of rebates to drugs dispensed for patients at Hy-Vee’s pharmacies could be positioned as a positive differentiator for the Hy-Vee PBM.”

Brian Anderson, a principal at Milliman Inc., says he also sees an opportunity for Hy-Vee’s PBM — dubbed Vivid Clear Rx — to carve out a niche.

“The challenge will be if Hy-Vee will be able to compete on a low net cost model,” he says. “The goal of most PBMs is to drive script volume, drive mail order and specialty. Their solution needs to be focused on driving the lowest cost options and engaging the pharmacist in a consultative way to mitigate waste and improve outcomes.”

Hy-Vee says its new subsidiary will offer PBM services to the company’s 88,000-plus employees “as well as other employers looking to maximize their employee benefits spending.”

The supermarket chain will partner with the technology company RxSense, which will provide Vivid Clear Rx “with a full-service suite” of PBM modules “that will supplement assets that Hy-Vee already owns and operates.”

Insurers Will Play Key Role in COVID Vaccine Distribution, Reimbursement

December 7, 2020

As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that payers will play in the process is becoming clearer.

It’s imperative for health plans to do two key things at the same time, according to Katherine Dallow, M.D., the vice president of clinical programs and strategy at Blue Cross Blue Shield of Massachusetts. Payers need to help the entities that will be distributing the vaccine to identify the individuals who should be first in line to be vaccinated, and they need to use their resources to help educate the community.

By Brian Eastwood

As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that payers will play in the process is becoming clearer.

It’s imperative for health plans to do two key things at the same time, according to Katherine Dallow, M.D., the vice president of clinical programs and strategy at Blue Cross Blue Shield of Massachusetts. Payers need to help the entities that will be distributing the vaccine to identify the individuals who should be first in line to be vaccinated, and they need to use their resources to help educate the community.

“We might be able to put a puzzle together that an individual provider or group may not have,” she said during a Nov. 18 National Institute for Health Care Management (NICHM) Foundation webinar. “Data from many sources should be used to ensure those who are most vulnerable are ID’d per federal and state guidelines. We can see where folks have seen three different doctors, used telehealth and gone to urgent care.”

In addition, health plans are more likely than providers to have better data about whether individuals have received each of their vaccine doses. That’s because states may expand the scope of the type of providers that can administer vaccines in an effort to broaden access.

While multiple vaccines appear ready to come to market, health plans do have some concerns. According to a recent Avalere Health survey of 39 U.S. health plans and one PBM, collectively representing about 48 million covered lives, the effectiveness of vaccines and therapeutics is the top COVID-19 concern for more than 47% of health plans.

For 25% of plans, their top concern is the cost of a vaccine. That said, 50% of payers expect to begin reimbursing for a COVID-19 vaccine within two months of authorization, and 78% expect to begin reimbursing in four months.

CMS released an Interim Final Rule with Comment Period on Oct. 28 requiring that all non-grandfathered individual and group private health plans cover a recommended COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing. The rule also says that “out-of-network rates cannot be unreasonably low,” and suggests as a reimbursement guideline the approved Medicare payment rate for a COVID-19 vaccine, which is $28.39 for a single dose and $16.94 for additional doses.