From Radar on Drug Benefits

New Generic HIV/AIDS Drugs Likely Won’t Have Large Impact

This article appeared in the Feb. 23, 2018 issue of RADAR on Drug Benefits. Subscribe today for biweekly business strategies and analysis for health plans, employers, PBMs and pharma companies.

By Jane Anderson
February 23, 2018Volume 19Issue 4

Several new generics for HIV/AIDS are on deck for the U.S., sparking hope among some observers that overall costs for the drug class will fall. But most of the generics are not expected to create significant disruptions in plans’ formularies for the HIV/AIDS class due to the complexity of HIV/AIDS treatment and the current practice of using once-a-day combination therapies, insiders tell AIS Health.

Two generic products have just been introduced: Mylan N.V. launched a generic version of Bristol-Myers Squibb’s Sustiva (efavirenz) on Feb. 1, and Teva Pharmaceutical Industries Ltd. launched a generic version of Gilead Sciences’ Viread (tenofovir disoproxil fumarate) on Dec. 15. Meanwhile, Laurus Labs, one of the biggest suppliers of ingredients used in HIV/AIDS medications, says it has received tentative approval from the FDA for its generic version of Viread.

Sustiva and Viread are mainly used in combination therapies with other drugs that still have patent protection.

In addition, Teva received FDA approval for a generic version of Truvada (emtricitabine and tenofovir disoproxil fumarate), Gilead Sciences, Inc.’s two-drug combination that’s used both for HIV/AIDS prevention (known as PrEP, or pre-exposure prophylaxis) and treatment. This drug could be a game-changer as a generic since Truvada generally is prescribed as a stand-alone pill. But after reaching a confidential settlement over patent litigation, Teva will not say when the generic might enter the market.

Therefore, despite a spate of new generics in this drug class, most analysts expect little to change in HIV/AIDS formularies in the near future.

“While the prospects of more generics becoming available for HIV drugs is exciting, significant uptake of generics will likely be challenging due to HIV treatment regimens that require triple and quad medication therapy cocktails,” says Lynn Nishida, area vice president, Solid Benefit Guidance. “The need to combine individual generic components — while certainly possible — will add an element of complexity and bring challenges in competing in a market that has been largely dominated for years as one pill once daily/all-in-one combination pills.”

Mesfin Tegenu, R.Ph., president of PerformRx, says the new generics do have some potential to decrease the overall cost of care for patients and payers, but “unfortunately, experience tells us that the cost of the individual generic products currently available hasn’t been really relevant since patients on combination therapy aren’t normally switched to individual drugs.”

Tegenu tells AIS Health that the vast majority of utilization is in these three- and four-drug combinations:

  • Gilead’s Atripla, which contains a combination of generic Sustiva, Emtriva (emtricitabine, not available as a generic) and generic Viread.

  • Complera, also from Gilead, a combination of Emtriva, Edurant (rilpivirine, not available as a generic) and generic Viread.

  • Genvoya, also from Gilead, a combination of Vitekta (elvitegravir, not available as a generic), Tybost (cobicistat, not available as a generic), Emtriva and Vemlidy (tenofovir alafenamide, not available as a generic).

  • Gilead’s Odefsey, a combination of Emtriva, Edurant and Vemlidy.

  • Stribild, also from Gilead, a combination of Vitekta, Tybost, Emtriva and generic Viread.

  • Viiv Healthcare’s Triumeq, which contains a combination of abacavir, Tivicay (dolutegravir, not available as a generic) and lamivudine.

Switching from these combination pills to three or four different pills wouldn’t be easy for patients and also would pose problems for providers, Nishida says. “Even with a significant cost reduction, getting prescribers and members to transition may also be difficult because of increased pill burden in taking individual components, and differing perspectives on [whether] taking combination products is for convenience or improved adherence. Also, just remembering the individual components in combination products can add to confusion in prescribing and dispensing errors.”

“In the treatment of HIV, switching a person to take two individual drugs instead of a two-drug combination has never been successful — we tried it with Combivir,” a combination of lamivudine and zidovudine that’s available as a generic, Tegenu says.

Since most plans cover the single-tablet HIV/AIDS regimens as first-line therapies, “we expect to see only a minor uptake” among generics, Tegenu says. “A majority of patients are started on single-tablet regiments. Therefore, until generics are available for these products, we expect to see only minor changes to generic utilization.”

Truvada Has Biggest Potential

Out of the various possible generics for HIV/AIDS, Truvada is the product with the most potential for uptake in the near future, Tegenu says, adding that it has the potential to generate savings for members and payers.

Nishida agrees, predicting that “this generic would likely gain a swift uptake by plans, largely because of one-to-one substitution for existing populations and new patients taking Truvada for PrEP and post-exposure prophylaxis. The degree to which plans will place prior authorization on the brand to divert prescriptions to the generic will likely depend on how fast the price of the generic falls relative to the brand as multiple manufacturers bring their generic versions to market.”

However, since Teva hasn’t said when it will launch generic Truvada and the drug’s future price isn’t known, it’s unclear when these potential savings might materialize.

For the Viread and Sustiva generics that have launched or are about to launch, it’s possible that some commercial plans may place them in lower cost-sharing tiers and make the copayment for the individual generic products more attractive, “and let the member decide whether they want to pay the premium price for the brand multi-drug product,” Tegenu says.

Jason Dohm, vice president, clinical account management at Express Scripts Holding Co., says his company has no plans to treat generic HIV medications any differently than other generic medications. “We will consider the generic for inclusion on the lowest copay tier and the brand on the non-formulary copay tier. The potential does exist that we will implement additional strategies to extract savings on behalf of our clients. It is too early to determine if we will require prior authorization for the brands.”

Mary Dorholt, Pharm.D., clinical practice lead at Accredo, Express Scripts’ specialty pharmacy arm, adds, “Prescribers and patients would likely have concerns about mandated generic use where it would require switching to multi-tablet regimens from a single tablet. Many patients are on a single tab regimen, which is likely a single copay — low or no copay if they have copay assistance. However, one-for-one generic substitution where the patient is taking the brand is likely to be more convenient for patients and prescribers.”

New Generics Could Increase Copays

The new generics aren’t “game-changers because there is not a one-for-one clinically equivalent generic option” that would work for the majority of those on combination therapies, says Dorholt. For example, for someone to switch from the drug Atripla to generics, that person would need to take three separate drugs instead of a single tablet. “This would also mean three copays for the patient instead of one,” she adds.

Compliance also could suffer with switching, Dorholt says. “The HIV management guidelines recommend the use of single tab regimens to improve adherence. Non-adherence can lead to increased medical cost from the need for increased laboratory monitoring, resistance testing and more frequent doctor visits.”

Tegenu adds: “Experience suggests that anytime you increase the number of tablets a person must take, or the frequency with which you have to take medications, compliance falls off dramatically.”

If multiple generics are used or encouraged to be used instead of combination products, plans should follow the best practice of tracking markers of medication adherence, such as medication possession ratios (MPRs) and proportion of days covered (PDCs), Nishida says. “Most plans commonly report their member populations taking HIV medications in the high 90%, with 100% corresponding to perfect adherence,” she says. “Lower MPRs or PDCs are a signal to plans to identify drivers of poor adherence and address with appropriate strategies and outreach to improve adherence if observed.”

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