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Mark E Helm 
Member since Jul 13, 2012


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Re: “UPDATE: Justice Dept. says drug firm campaign contribution spurred helpful Ark. law

Mike Mitchell and GSK's characterization of the Advair (combination asthma controller)Medicaid policy is inaccurate. This was not a "fail first" or step therapy edit as Mitchell (and GSK) asserted. Patients and prescribers could (did, and continue to) readily start controller treatment with a combination product.

The policy relating to Advair and all subsequent combination asthma controller products was a response to clear evidence that Advair was widely misused in the Arkansas Medicaid population. This misuse related to GSK's aggressive promotion, as well as to the generally poor awareness among prescribers that the overwhelming majority of patients were not consistently using either Advair or other inhaled asthma controller medications.

For the majority of patients, asthma is only an occasional problem, and sypmtoms are infrequent. For some asthamatics, the condition is persistent - causing symptoms several times a month, several times a week or possibly even daily. Persistent asthma is the only type requiring a daily controller treatment. The foundation of daily asthma treatment is an inhaled steroid, not a combination product.

With consistent use of an inhaled steroid, additional treatment is not often needed. Advair or the combination brands introduced later (Symbicort and Dulera) are fine and useful treatments for asthma when it can not be managed with an inhaled steroid alone. These combination products are the "fourth level" of treatment for asthma.

For any of the daily medicines to deliver on their promise of decreasing persistent asthma symptoms, patients should actually receive at least 80% of the prescribed number of doses.

The Arkansas Medicaid policy permitted any patient who approached consistent use of a combination asthma controller to continue to receive the medication. Using an automated review process, patients who had markers for severe persistent asthma were also automatically cleared to receive authorization for the combination controller. Severe asthma patients could be identified based on ER visits, hospitalizations or the frequency of treatment with oral steroids for asthma in the most recent 2 years. Any patient with near consistent use of an inhaled steroid (2/3 of intended doses) for a period of time could also "step-up" treatment to a combination controller without a "prior authorization."

Finally, any prescriber could request authorization to start daily treatment with the combination controller, provided that they documented lung impairment with pulmonary function testing (a simple test which anyone treating asthma should be equiped to do in their office) or symptoms which supported the diagnosis of "moderate to severe" persistent asthma. The prior authorization process was designed to provide a rapid response to a prescriber (or their staff) with a brief call to one of the two pharmacy prior authorization centers for the Medicaid program.

There was never a requirement to "fail" treatment with an inhaled steroid.

There was an expectation that Arkansas Medicaid providers should follow the guidance of the NIH/National Heart Lung Blood Institute on asthma treatment, and an expectation that providers would do the necessary diagnostic work to determine the severity of a patient's asthma.

This was a highly sophisticated policy, based firmly on the science of asthma treatment, and the realities of asthma care in Arkansas. It was explicitly designed to improve the quality of asthma care. GSK never wanted to understand it, and worked hard around the state to misrepresent it. This policy also happened to result in dramatically lower costs for the Medicaid program.

Extensive policy analysis after the first year of the policy revealed that there were no negative consequences (except for GSK's Advair market share). Asthma patients appeared to have more appropriate contoller products selected. Providers apparently recognized asthma symptoms and treated them with appropriate use of approved, fast-acting asthma rescue medicines, rather than prescribing Advair inappropriately. Costs (both for medicines and medical services), hospitalizations, ER visits and even office visits either fell or at least failed to show any increase.

I know these things because I am a physician, a Medicaid provider, and I designed the policy.

1 like, 0 dislikes
Posted by Mark E Helm on 07/13/2012 at 8:02 PM

 

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