As of the start of 2014, several pharmacy benefits managers (PBMs) including Express Scripts and CVS Caremark companies that administer prescription drug benefits in the United States removed as many as 50 popular brand-name drugs from their national formularies. Several of these decisions will strongly impact the asthma and COPD markets, namely removal of key GlaxoSmithKline (GSK) respiratory drugs such as Advair, Flovent and Breo (although these exclusions do not apply to Medicare plans, so the effect on the COPD market will be more muted than seen for asthma).

In practice, this means that many asthma and COPD patients who were taking a commonly prescribed drug such as Advair (a fixed-dose combination of a long-acting beta2 agonist [LABA] salmeterol and an inhaled corticosteroid [ICS] fluticasone propionate), will now be asked to choose an alternative, cheaper member of the same drug class, such as Symbicort or Dulera. Although thought leaders do not commonly cite major efficacy differences between different members of this drug class, it is unclear how any given patient whose respiratory disease is adequately controlled on Advair will react to an alternative LABA/ICS combination. In the United States, Advair was one of the top ten drugs in terms of both prescriptions and sales in 2013. It is unclear at this point how many patients in practice who currently receive Advair will actually be required to switch to a different LABA/ICS combination, but this development could still result in a significant hit to Advair's blockbuster status. Symbicort has already successfully penetrated Advair's market to a degree in recent years, capturing increased patient share, and actions like this from PBMs will only accelerate these gains.

In addition to forcing patients to switch from Advair or Flovent to a cheaper LABA/ICS combination or ICS, this decision from PBMs will also limit the foothold that newly-launched Breo will be able to grab in in the respiratory market that GSK to one far below GSK's original hopes. Breo offers once-daily dosing, the first for a LABA/ICS fixed-dose combination, something that could have implications for improving compliance, and therefore disease outcomes, for patients. The questions thus arises, will GSK be willing to negotiate discounts with these PBMs in an effort to ensure formulary coverage. Novartis dealt with a similar situation last year in the United Kingdom where NICE the domestic body in charge of reimbursement decisionsdecided to remove Xolair from NHS coverage. However, Novartis managed to persuade NICE to reverse this decision at the last minute by offering a new patient access scheme, ensuring the drug remained reimbursed for asthma patients.

To date, GSK has appeared largely unconcerned by these developments but it is to be assumed that strategies to recover reimbursement for its drugs are currently under consideration. One strategy investigated by Decision Resources Group that may allow a blockbuster drug such as Advair to retain its patient share is by targeting plans where Accountable Care Organizations (ACOs) are utlized.  A recent U.S. Physician & Payer Forum report, Accountable Care Organizations: How Will Payer and Provider Adoption of This Model Impact Prescribing Trends in Asthma and COPD, from June 2013 found that roughly half of managed care organizations (MCOs) that pay for Advair reported that Advair prescribing increased because of ACOs, suggesting that a drug such as Advair that is perceived to be more effective than its competitors can retain patient share. Half of pulmonologists whose ACOs monitor adherence, which can be a surrogate for ACOs primary goal, also cited LABA/ICS combinations as a key drug, suggesting that Advair, and possibly once-daily Breo, could excel in such a setting. Thus, GSK may look to dedicate time to ensuring both payers and prescribers involved in ACOs are aware of the advantages its asthma and COPD therapies offer over competitors.

In any case, it will be interesting to see what impact these changes have on the respiratory disease markets and what strategies GSK decides to employ in response to decreased Advair prescriptions and a reduced market share for Breo compared with what was once hoped for.

Colleen Albacker, Ph.D., is a business insights analyst with the Immunology team at Decision Resources Group.

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