Transcript 1312-Laing-_b

Assessment, pricing, and reimbursement of new health technologies:
Innovative reimbursement models: Examples from health insurance systems in Asia
Abdulkadir Keskinaslan, MD, MBA, MPH
International Conference for Improving Use of Medicines – ICIUM 2011
Antalya,Turkey, November 17, 2011
Striking a Challenging Balance
Continued innovation
Access to new medicines
2 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Appropriate use
Household & system affordability
The underlying concept of innovative pricing and patient
access schemes is value-based pricing
 In an increasingly cost-sensitive environment, it is becoming more difficult
for highly-priced innovative drugs to gain reimbursement
 Pharma is now moving towards a value-based pricing system, opting for
risk-sharing in an effort to improve equitable access to effective care
 Innovative pricing and patient access schemes are arrangements which
may be used on an exceptional basis for the acquisition of medicines
 The schemes are intended to improve the cost-effectiveness of a medicine
and therefore allow HTA bodies to recommend treatments which they would
otherwise have deemed not cost-effective
Risk-Sharing Agreement:
“A contract between two parties who agree to engage in a transaction in which there are
uncertainties regardless concerning its final value. Nevertheless, one party, the company,
has sufficient confidence in its claims of either effectiveness or efficiency that it is ready to
accept a reward or a penalty depending on the observed performance.”
Source: Akehurst,Taiwan HTA Workshop 2010; de Pouvourville, EJHE, 2006
3 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
From “Price Volume” and “Money Back” to Value Based
Reimbursement: Non-linear pricing
 Price-Volume Agreement assumes that
high
“reimbursement buckets” are filled from
left to right
 Money-back Guarantee assumes
binary outcome: full response or failure
P3
 Is it possible to devise a scheme, where
Weighted Average Price
Average Price
all “buckets”! Are filled simultaneously,
depending on patient characteristics
(e.g. unmet need, risk, benefit)?
P2
low
P1
S1
S2
Size of Patient segment or indication
4 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
S3
Pricing models to improve access and affordability
Financial Utilization
Models
Outcomes Based
Pricing Models
Initial 10% of patients
Full response
Next 20% of patients
Risk Based
Pricing Models
High Risk
Partial response
All others
Moderate risk
No response
Patient segments
Patient segments
 Price volume agreement: e.g.
 Money back guarantee, e.g.
full reimbursement for first
10% of patients, reduced
reimbursement for next 20%
of patients, no reimbursement for all others
full reimbursement for
responders, reduced
reimbursement for partial
responders, no reimbursement for non-responders
5 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Low risk
Patient segments
 Reimbursement linked to
value and level of risk factors
(e.g. based on diagnostic test)
Lucentis (ranibizumab) for AMD – UK
Per patient, response-assumed, if longer treatment required, drug free of charge
Financial Utilization
Models
 In 2008 NICE found Lucentis to be cost-effective for wet Age-Related Macular
Degeneration (AMD) if a course of treatment did not exceed 14 injections
 To ensure full patient access, Novartis agreed to pay for any injections of
Lucentis that exceeded the 14 recommended by NICE
• Company covers the costs of additional injections
Results
 Patients received effective innovative treatment
 Improved cost effectiveness for the NHS
 Lucentis became established as effective treatment in the market
Source: National Institute for Health and Clinical Excellence.
Final Guidance: Ranibizumab and pegaptanib for age-related macular degeneration.
http://guidance.nice.org.uk/TA155
6 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Velcade (bortezomib) for multiple myeloma - UK
Per patient, response dependent, cash refund
Outcomes Based
Pricing Models
 In 2006, Velcade treatment was considered ‘not cost-effective’
• costs approx. £3,000 per treatment cycle (£38,000 per QALY).
 Johnson & Johnson scheme proposed that treatment would be reimbursed
only when effective
• Full or partial response - remain on therapy and funded by NHS
• minimal or no response - cease treatment and costs refunded to NHS by the
company
 ICER with rebate, stopping rule after 4 cycles with partial and full
responders continuing therapy: £20,700/QALY
• Response assessed after max of 4 treatment cycles and response was measured
by tumor shrinkage
- reduction in serum M-protein levels of 50% or more
• 60 day claim period
Source: A Keskinaslan, ISPOR Asia, Thailand September 5-7th, 2010
7 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Actonel (risedronate) for osteoporosis – US
Per patient, response dependent, pay for consequence
Outcomes Based
Pricing Models
 In 2009 Procter & Gamble and Sanofi-Aventis agreed the scheme with Health Alliance
Medical Plans
 A risk-sharing agreement where preventative treatment is assessed against unwanted
disease outcomes
• To pay for bone fractures occurring while the patient is taking Actonel.
• For these patients, any health costs associated with a non-spinal fracture to be covered by the
manufacturing companies (estimated to cost between $6,000 and $30,000 per fracture,
depending on the fracture location).
 Patients qualify if they have no-comorbidity, no prior fractures etc; and have taken
Actonel for six out of the nine most recent months
 Intention of the scheme:
• To reduce potential treatment costs for fracture treatment for patients on Actonel
• To provide an incentive to keep qualified patients on Actonel instead of switching to lessexpensive generic alternatives
• To keep Actonel on a lower formulary tier than competition
8 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Source: A Keskinaslan, ISPOR Asia, Thailand September 5-7th, 2010
Telbuvidine for chronic hepatitis B treatment - Australia
acceptable ICER across patient segments
Risk Based
Pricing Models
 Telbuvidine is indicated for the treatment of HBeAg-positive and HBeAgnegative chronic hepatitis B patients who have compensated liver
disease, evidence of viral replication and active liver inflammation and
who are nucleoside analogue naïve.
 Telbuvidine priced at weighted average price across patient subgroups
• priced at a high but acceptable incremental cost effectiveness ratio compared
to lamivudine for HBeAg-positive (e-pos) patients
• priced higher than lamivudine for HBeAg-negative patients based on costoffsets due to reduced resistance rates and thus lower use of more expensive
2nd-line adefovir
Source: http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-telbivudinemar08; www.novartis.com.au/DownloadFile.aspx?t=p&f=seb.pdf&dateid
9 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
The underlying concept of patient access schemes is no
different from innovative pricing schemes: value-based pricing
Willingness to Pay Based
Pricing Models
Affordability Based
Pricing Models
Discount for members
Price or free goods
reward for compliance
Full price
Partial price
Value added services
for compliant patients
Patient segments
 Loyalty Card: e.g.
progressive discounted price
for members, additional
reward for compliant patients
(4+1), value added services
(free routine tests) for long
term compliant patients
10 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
No price
Patient segments
 Patient Assistance Program, e.g.
Patients pay what they can afford,
governments or private insurance
companies may contribute
NOA providing Glivec (imatinib) for CML - Indonesia
Affordability based model, shared contribution
Affordability Based
Pricing Models
 Novartis Oncology Access (NOA) designed to bridge the
affordability gap in Indonesia
 NOA offers patients to pay what they can afford, based on a
financial evaluation – to bridge the affordability gap.
• Co Pay Model Based on the “Cost of Living Wages” (CoL)
• Patient’s financial resources do not fall under 2 X CoL after purchasing
Glivec
• 7 tier scheme determined through assessment made by financial
agency; in December, 2010: 305 patients
Full price
Partial price
No price
 Multiple Stakeholders involved in setting up the program
• Ministry of Health Indonesia
• Indonesian Society of Hematology and Blood Transfusion
Patient segments
• Indonesian Hematology and Internal Medicine Medical Oncology
National Working Group
• Indonesian Cancer Foundation, Jakarta Branch
• Financial assessment by PT Survindo Putra Pratama
• Novartis Indonesia
11 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Lucentis (ranibizumab) for AMD – UAE
Affordability based model with shared contribution
Affordability Based
Pricing Models
 Novartis introducing MUSANDA Program, a patient
access & affordability program which enables
ophthalmologist to treat a segment of patients that was
left with no treatment
Partial price for
all segments
 Program helps patients with funding gap and creates a
financing option for self-pay patients
 It helps restoring sight and prevent blinds & visual
impairment for AMD/DME patients
Patient Purchase
 Program also offers discounted fees for patients at
affiliated clinics and hospitals
Patient segments
 3rd party conducts financial assessment to identify
eligibility for different level of support
12 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Musanada program designed to help patients with no access
Patients wAMD & DME for MUSANADA program :
13 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011
Affordability
barrier
No Access
Q&A
[email protected]
Examples of Estimated ICER Thresholds
Unit
Lower boundary
Upper boundary
USA
QALY
US$50,000
US$100,000
Canada
QALY
US$17,600
US$87,800
LYG
US$28,200
US$51,000
UK
QALY
US$32,000
US$48,000
Thailand
QALY
~US$2,000
~US$8,000
Unit
Lower boundary
Upper boundary
Australia
WHO
GDP/capita/DALY averted
<3
Australia
PBAC
GDP/capita/life-year
gained
1.26
2.29
UK NICE
GDP/capita/QALY
1.4
2.1
If the ICER is within a defined acceptable range (threshold) by the payer/ provider of
healthcare, then there is a high likelihood that the treatment could be accepted
ICER = incremental cost-effectiveness ratio; QALY = quality-adjusted life-year; LYG = life-years gained;
GDP = gross domestic product; WHO = World Health Organization; DALY = disability adjusted life-years;
NICE = National Institute for Clinical Excellence (UK); PBAC = Pharmaceutical Benefits Advisory Committee
Value in Health 2004;7:518
15 | Innovative Reimbursement Models | Keskinaslan | 17 Nov 2011