The prevalence of Parkinson’s disease (PD) will approach 3 million cases in the major pharmaceutical markets by 2023. A substantial portion of PD patients fall in the intermediate to advanced disease stage and are experiencing levodopa-induced motor response complications (MRCs), such as motor fluctuations and dyskinesias. MRCs are one of the primary ongoing clinical challenges in the management of PD and represent a viable opportunity for new therapeutic interventions. The PD pipeline is rich with emerging therapies, many of them targeting MRCs, including reformulations of current agents, new drugs from current PD drug classes, and therapies with new-to-PD mechanisms of action, such as adenosine A2A receptor antagonists. However, the extent to which therapies in development will fulfill the unmet need to better address MRCs remains to be seen.
Questions Answered in This Report:
- Improving global outcome, relief of primary motor symptoms, and management of treatment-related complications are key goals in the treatment of intermediate to advanced PD. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European neurologists weight specific efficacy end points and other drug attributes in their prescribing decisions for intermediate to advanced PD?
- Effect on activities of daily living (UPDRS Part II score) and effect on primary motor symptoms (UPDRS Part III score) are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for most new intermediate to advanced PD therapies. What trade-offs across these and other clinical attributes are U.S. neurologists willing to make when considering the use of emerging therapies for the treatment of intermediate to advanced PD? Based on the trade-offs in price and performance across key drug attributes that U.S. neurologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for intermediate to advanced PD?
- By 2018, IPX-066 (Impax Laboratories’ Rytary) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is IPX-066 most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by IPX-066?
Attributes included in conjoint analysis-based assessment of target product profiles for intermediate to advanced PD:
- Effect on total “on” time and quality “on” time (hours/day), adjunct to levodopa (placebo-adjusted).
- Effect on primary motor symptoms (UPDRS Part III score), adjunct to levodopa.
- Effect on activities of daily living (UPDRS Part II score), adjunct to levodopa.
- Risk of hallucinations (% of patients).
- Rate of minor side effects (% of patients).
- Delivery profile.
- Price per day.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for intermediate to advanced PD:
- Levodopa reformulation with less-frequent dosing.
- Levodopa-adjunct therapy with an improved effect on motor fluctuations.
- Non-injectable rescue therapy for “off” episodes.
- Adjunct therapy with an effect on PD-associated psychosis.
Physicians surveyed: 60 U.S. and 30 European neurologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Rasagiline (Teva/Lundbeck’s Azilect)
- Pramipexole ER (Boehringer Ingelheim’s Mirapex ER/Mirapexin ER/Sifrol Retard/Mirapex LA, generics)
- Rotigotine (UCB/Otsuka Pharmaceutical’s Neupro/Neupro Patch/Leganto)
- Entacapone (Novartis/Orion Pharma’s Comtan/Comtess/Stalevo, generics)
- Apomorphine (U.S. World Meds/Britannia/Kyowa Hakko Kirin’s Apokyn, other brands, generics)
- Levodopa (Merck/Bristol-Myers Squibb/DuPont Pharma’s Sinemet, Sinemet CR, other brands, generics)
- IPX-066 (Impax Laboratories’ Rytary)
- Safinamide (Newron Pharmaceuticals/Zambon Pharma/Meiji Seika Pharma’s Xadago)
- Istradefylline (Kyowa Hakko Kirin’s Nouriast)
- CVT-301 (Acorda Therapeutics)
- APL-130277 (Cynapsus Therapeutics)