Academic journal article Health Care Financing Review

Open Access to Innovative Drugs: Treatment Substitutions or Treatment Expansion?

Academic journal article Health Care Financing Review

Open Access to Innovative Drugs: Treatment Substitutions or Treatment Expansion?

Article excerpt

INTRODUCTION

Many health plans and State Medicaid Programs use preferred drug lists and prior authorization to restrict the use of newer, more expensive medications within a given therapeutic class. Formulary restrictions are particularly common for new subclasses of medications immediately after their approval by the FDA as it is not yet clear how well these newer medications will work as substitutes for older drugs in real-world clinical practice. It is also common for health plans and Medicaid Programs to modify or drop prior authorization restrictions over time if evidence mounts documenting the advantages of substituting newer products for older drugs.

Removing formulary restrictions on new medications (open access) may produce two very distinct changes in treatment patterns for chronic disorders. Open access is intended to facilitate the substitution of innovative drugs for conventional medications among the population of patients who would normally use drug therapy under prior authorization restrictions, either as their initial drug therapy or as replacement therapy for an active drug regimen using older medications (substitution effects). However, open access may also alter physician/patient decisions about if and when to initiate treatment if these medications are considered to be safer and/or better tolerated than older products. These access effects may be most pronounced for three distinct patient groups. For novice patients, access to new medications with better safety profiles may induce physicians to initiate therapy for less severely ill patients. For example, a long-term change in the clinical threshold for drug therapy was observed in the California Medicaid (Medi-Cal) Program when it dropped restrictions on the use of Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants in May 1996 (McCombs et al., 2003).

Open access may also induce treatment refractory patients and patients who were sensitive to the older medications' side effects to restart drug therapy using the innovative medications. Similarly, patients currently using conventional medications may add a new drug to their current drug regimens (augmenting) once open access is granted. If these access effects do exist, then patients restarting or augmenting therapy under open access may do so without experiencing the usual acute exacerbations of symptoms that typically preceded restarting or changing therapy under closed access. Moreover, the surge in use from these forms of the access effect may be a relatively short lived once the pent-up demand for new treatment options is satisfied.

In October 1997, Medi-Cal granted open access to three second-generation antipsychotic medications: risperidone, olanzapine, and quetiapine. Prior to this date, the use of a second-generation antipsychotic medication required prior authorization verifying that the patient had failed therapy using two conventional medications, such as haloperidol, perphenazine, thioridazine, or chlorpromazine. Both substitution and access effects could significantly influence how this open access policy affected patient outcomes and the cost of treating severe mental disorders. Substitution of newer antipsychotic medications for older medications is expected to improve average patient outcomes. However, the impacts of access effects on patient characteristics, and therefore on average outcomes, are difficult to predict. For example, if less severely ill patients were treated with antipsychotics under open access or the use of antipsychotics was expanded to other disease states (e.g., bipolar disorders), then average duration of therapy may be reduced. If treatment refractory patients returned to restart therapy, then both average duration of therapy and treatment costs could fall if a few hig-cost, refractory patients benefit from the newer medications. All three access effects could significantly alter the characteristics of the patients receiving drug therapy in the open access period relative to patients treated previously. …

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