Will Part D Redesign Lower OOP Costs for HIV Care?
The IRA’s Part D redesign could lower out-of-pocket costs for people with HIV; providers can help make sure their patients are aware of these changes.
CMS Selects First 10 Drugs for Medicare Negotiation
CMS selected 10 Part D drugs for the first year of negotiation. Stakeholders should consider engagement opportunities and evaluate broader therapeutic dynamics.
How May the IRA Shift Part D Market Dynamics?
IRA policies and growing enrollment in Medicare Advantage could begin to destabilize the standalone PDP and LIS benchmark plan market.
How Will the IRA Impact the Future of Biosimilars?
Multiple Inflation Reduction Act provisions impact biologics and biosimilars, but the net impact and potential consequences will vary across products.
How Did Public Comments Shape Revised Negotiation Guidance?
Comments on initial negotiation guidance significantly shaped the revised guidance, underscoring the importance of stakeholder engagement in IRA implementation.
How Do IRA Policies and the Enhancing Oncology Model Interact?
Manufacturers should adjust commercial and evidence generation strategies in response to the shifted incentives under the IRA and Enhancing Oncology Model.
How Can Patients and Caregivers Participate in Negotiation?
Recently released guidance and a second draft Negotiation Data Elements ICR introduce several opportunities for patients and caregivers to shape negotiation.
Avalere Experts Respond to Revised CMS Negotiation Guidance
The revised guidance contains significant changes to the initial guidance released in March, but important outstanding questions remain.
How Do IRA Policies and Part D Risk Adjustment Interact?
The IRA will increase health plans’ financial risk, elevating the importance of Medicare Part D risk adjustment.
How Does the IRA Affect Providers’ and Pharmacies’ Strategies?
Providers and pharmacies are two critical stakeholders that should prepare their own IRA strategies to adequately react to a changing landscape.
Plan Finder Will Play a Key Role in Part D Redesign
Beneficiary interviews show the importance of Medicare Plan Finder as a resource and generated ideas to incorporate IRA reforms and improve user experience.
How Will the IRA’s Part D Changes Affect Plan Strategies?
Plans preparing MA-PD and PDP bids for Plan Year 2025 should consider how Part D redesign will affect enrollee costs, plan payment, and market dynamics.
Which Therapeutic Areas Are Likely to Be Affected by IRA Negotiation?
Sponsors with portfolio or pipeline assets within certain therapeutic areas can prepare for the downstream effects of price negotiation on the market.
Should Competitors of Negotiated Drugs Review Their Market Strategies?
Manufacturers of therapeutic alternatives to negotiation-eligible drugs should re-examine their commercialization strategies in response to market dynamics.
Should Competitors of Negotiated Drugs Review Their Evidence Strategy?
Manufacturers of therapeutic alternatives to negotiation-eligible drugs should examine their value and evidence strategy in response to new dynamics.
Will the IRA Change Investment in Orphan Drug Pipelines?
IRA negotiation eligibility criteria may impact orphan drug investment, affecting long-term innovation and patient access.
How Do IRA Drug Pricing Policies Interact with One Another?
Stakeholders should consider the interaction of inflation-based rebates, AMP cap removal, and Medicare price negotiation in pricing and contracting strategies.
Insights on IRA Policies and Business Impacts Presented at Asembia
Avalere’s expert presentations at the AXS23 Summit described IRA drug-pricing policies and the law’s impact on patient access and affordability.
Do Drug Manufacturers Have the Evidence Needed for Price Negotiation?
Manufacturers may find significant gaps between their existing evidence and the negotiation data elements that CMS will evaluate during the negotiation process.
Operational Complexities of Providing Access to MFP for Part D Drugs
Stakeholders in the drug supply chain should consider operational complexities that will result from variable arrangements for accessing the MFP.