Laws Laws & & Regulations in an Regulations in an - - PowerPoint PPT Presentation

Laws Laws & & Regulations in an Regulations in an E l i H lth E l i H lth M k t l k t l Evolving Healthcare Evolving Healthcare Marketplace arketplace

Real Life Implications for Biopharmaceutical Industry Real Life Implications for Biopharmaceutical Industry

Christi Shaw

Head, US General Medicines President Novartis Pharmaceuticals Corporation President, Novartis Pharmaceuticals Corporation February 17, 2016

1 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

Shifting from Volume to Value Shifting from Volume to Value

Access

Improve Population p Health

Triple Aim Quality Cost Aim Quality

Improve Individual Experience

• f Care

Cost

Reduce Per Capita Cost of Population Care

The healthcare industry is embracing change, f f The healthcare industry is embracing change, f f

2 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

but can only advance so far with the current infrastructure but can only advance so far with the current infrastructure

Laws impacting shift to value Laws impacting shift to value-

• based healthcare

based healthcare

S & S &

1 2 3

Stark Law & Anti-kickback Statutes Stark Law & Anti-kickback Statutes Patient Privacy Rules Patient Privacy Rules Limiting FDA Regulations Limiting FDA Regulations

3 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

Stakeholders want to create new patient solutions Stakeholders want to create new patient solutions

4 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

Thinking outside the box Thinking outside the box

5 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

Anti Anti-

• kickback statutes don’t

kickback statutes don’t always take into account always take into account current healthcare current healthcare payment and delivery models payment and delivery models

How can we all think and work more creatively for the benefit of improved healthcare outcomes?

1

How do we step out of our silos and work across the system?

2

How can pharma manufacturers work more directly with ACOs

• r other integrated care entities?

3

NDHI Recommendation

Greater flexibility and new anti-kickback statute safe

NDHI Recommendation

Greater flexibility and new anti-kickback statute safe

• r other integrated care entities?

3

6 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

Greater flexibility and new anti kickback statute safe harbors to achieve increased quality and lower costs Greater flexibility and new anti kickback statute safe harbors to achieve increased quality and lower costs

We need greater flexibility to We need greater flexibility to SHARE SHARE scientific and health economic data scientific and health economic data

• Sharing scientific and healthcare

economic information with stakeholders BEFORE FDA approval can help improve payers’ ability to plan for future healthcare costs

• Establishing metrics for outcomes-based

contracts is currently limited to product label primary endpoints which may not align with payers’ preferences

7 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

8 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016

Thank You Thank You

9 | National Dialogue Healthcare Innovation | Christi Shaw | February 2016