SESSION #7: Bringing Patient Centricity to Diabetes ...Patient-Centricity: Health Policy and Patient...

SESSION #7: Bringing Patient Centricity to Diabetes

Medication Access

Canadian Association for Population Therapeutics/ Association Canadienne pour la Thérapeutique des Populations Annual Conference

Topics • What is the magnitude of the challenge of diabetes in Canada,

now and in the future? • How does Canada compare to other jurisdictions, in terms of

access to appropriate treatment, financial burden on patients and long-term outcomes?

• What are the unmet needs for clinicians and people living with diabetes?

• How do we get to patient-centric treatment for people living with diabetes?

• How are theses issues viewed from the perspective of the payer and the person living with diabetes?


Speakers • Jan Hux - Diabetes Canada • Judith Glennie - J.L. Glennie Consulting Inc. • Katharina Kovacs Burns - University of Alberta • Judy McPhee – formerly Nova Scotia Pharmacare • Kim Hanson - Diabetes Canada

Global Diabetes Burden

415 M in 2015

IDF: Cost-effective solutions for the prevention of type 2 diabetes

“even in countries where publicly-funded health care exists, access to all necessary care is not guaranteed.” “those who experience financial barriers have significantly higher rates of hospitalization and mortality”

The Burden of Diabetes

• 3.5 M Canadians have been diagnosed with diabetes – the number has doubled in the last 12 years

• Nearly 1M live with undiagnosed Type 2 • More than 6M meet criteria for prediabetes • Another Canadian is diagnosed every 3

minutes

The Evolving Epidemic in Canada

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Diabetes prevalence in Canada, 2000–2025

T1DM Prevalence T2DM Prevalence Prevalence Rate (right axis)

2015 Report on Diabetes: Driving Change. CDA

The Burden of Diabetes

At a time when people with diabetes made up 6% of the population, they accounted for:

• 30% of the strokes • 40% of the heart attacks • 50% of kidney failure requiring dialysis • 70% of amputations

Life expectancy may be shortened by 5-15 years.

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Beyond Chronic Complications • The relentless “dailiness” of diabetes • Misunderstanding and stigma • Lost opportunities • Isolation

Not all bad news

• While growth in diabetes rates is an unprecedented public health challenge, need to look at the story behind the growth

• Half of the growth in prevalence is due to improved survival!

• Availability of effective, evidence-based therapies is changing the face of diabetes

Diabetes Complication Rates over Time

Gregg et al. N Engl J Med 2014; 370:1514-1523

Research-based treatments offer great benefit

But those benefits…. …. only accrue to those who can access the therapies! Patients need to have the therapy prescribed and the resources to pay for it.

Clinical Inertia Delays in Intensifying Therapy in Type 2 Diabetes

Khunti, Diabetes Care, 2013

Why do Providers Delay?

• Delay is more common in chronic preventive therapies where symptoms don’t drive prescribing

• Clinical inertia is due to at least three problems:

• overestimation of care provided • use of “soft” reasons to avoid intensification of

therapy • lack of education, training, and practice

organization aimed at achieving therapeutic goals

Phillips, Ann Int Med, 2001

Even with a prescription in hand… … patients may find cost to be a barrier in accessing optimal therapy

Access to Insurance

Lack of Coverage by Income

Out-of-Pocket Costs Impact Adherence

Access to evidence-based therapies for people with diabetes

• Requires informed and supported providers • Is highly dependent on access to insurance

coverage • And in turn, to what products are included in

insurers formularies

How Patient-Centric is Public Reimbursement of Diabetes Therapies?

Dr. Judith Glennie J.L. Glennie Consulting Inc.

Reproduction requires permission of J.L. Glennie Consulting Inc.


Patient-Centricity and Evidence Assessment


What are payers/HTA bodies looking for? • Saxagliptin (June 2010):

• “The relationship between hemoglobin A1c and vascular outcomes may differ for new drug classes with novel mechanisms of action. Evidence suggests that hemoglobin A1c has greater validity as an outcome for interventions when a relationship between hemoglobin A1c and patient-important outcomes, such as macrovascular outcomes, has been previously established.”

• Linagliptin (Feb 2012): • “The Committee noted that none of the reviewed trials were designed to

examine the effects of linagliptin on microvascular or macrovascular outcomes, and that the relationship between hemoglobin A1c and vascular outcomes may differ for new drug classes with novel mechanisms of action, and between drugs within a class.”

• “The Committee noted that there is an ongoing trial (CAROLINA) to evaluate the cardiovascular safety of linagliptin compared with glimepride in patients with type 2 diabetes and high cardiovascular risk.”

• Key gap: no/limited patient input

• Key future driver: FDA requirements for major CV safety outcome trials

CADTH looking for an assessment of the relationship b/t HbA1C and CV outcomes directly attributed to new molecules.

CADTH looking for both molecule-specific data related to impact on micro/macro-vascular outcomes, as well as an assessment of the

relationship b/t HbA1C and CV outcomes directly attributed new molecules.


History of CADTH DM 3L Reviews Year Results Insights 2010 • insulin preferred 3L

agent (after MET+SU) • Rationale: lower unit

cost vs. other 3L agents

• Insulin is 3L agent of choice due to cost compared to newer agents

• Limited accounting for patient challenges in using insulin, -ve impacts of insulin therapy

• No consideration of clinical or economic impact of paradoxical and potentially detrimental weight gain associated with insulin use in T2DM

• No patient perspectives or preferences in evidence base of evaluation

2013 • same position as 2010 • DPP-4 could be added

to MET+SU “in the rare instances when insulin is not an option”

Reproduction requires permission of J.L. Glennie Consulting Inc. 4

MET = metformin; SU = sulphonylurea; T2DM = type 2 diabetes; 2L = 2nd line; 3L = 3rd line

Draft: Second-Line Therapy for Type 2 Diabetes CADTH Therapeutic Review (January 2017)

Draft economic report: • Downplayed outcome measures important to patients

• Downplayed costs associated with complexity of care, etc. with

insulin • Recommendations not aligned with major clinical bodies + other

HTA bodies + many provincial criteria – NICE = oral agents (e.g., DPP4s and SGLT2s) for 2L and 3L – Many provinces = BROAD criteria to align medication access with policy

priorities


Handling of Emerging CV Benefit Data: Data vs. HTA Perspectives

Study/Products CV benefit data HTA Reports

EMPA-REG (2015)

• 14% ↓ combined MI + stroke + CV death

• 38% ↓ in CV death

CDR: recommended Jardiance as an add-on to MET to ↓ CV death in T2DM patients with established CV disease DM TR (draft): • acknowledged demonstration of lowered rate of CV outcomes

and death • then proceeded to ignore these benefits and leave them out of

the model for the economic evaluation “due to uncertainty with the limited evidence available on cardiovascular effects”

CVD-REAL (2017) (real-world use of SGLT2s)

• 39% ↓ heart failure hospitalization rate

• 51% ↓ in death from any cause

DM TR (draft) – see above

LEADER (2016)

• ↓ 13% in MACE • 22% ↓ in CV death

DM TR (draft) - see above

REPRODUCTION REQUIRES PERMISSION OF J.L. GLENNIE CONSULTING INC. 6

Assessment: Public payer approach may be undermining efforts to improve diabetes care and mitigate major causes of disability, health care costs, and death.

Final: Second-Line Therapy for Type 2 Diabetes CADTH Therapeutic Review (May 2017)

• For adults with type 2 diabetes without established cardiovascular

disease, add a sulfonylurea drug to metformin once metformin, diet, and exercise are not enough to control blood glucose levels.

• For adults with type 2 diabetes with established cardiovascular disease, refer to the CADTH Common Drug Review (CDR) recommendations on individual drugs that have been reviewed for this indication.


“As of May 2017, the only drug reviewed by CDR for this indication is empagliflozin (Jardiance). The recommendation is to reimburse empagliflozin for patients with type 2 diabetes as a second-line therapy after metformin if these patients have established cardiovascular disease as defined in the EMPA-REG OUTCOME trial.”


Patient-Centricity and Equity of Access


Diabetes Medications: Impact of Private vs. Public Payer Perspectives

Drug Class (products)

Private Payers Public Payers

DPP4s (e.g., Januvia, Onglyza, Trajenta, Nesina)

Available Highly variable (not listed - restricted access – open access)

SGLT2s (e.g., Invokana, Jardiance, Forxiga)

Available Not listed or restricted access (exception: QC – open access for all; ON – open access for Invokana only)

GLP-1s (e.g., Trulicity, Byetta, Victoza, Eperzan)

Available Not available (exception: Victoza, Trulicity available in QC)

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Diabetes Canada - September 5, 2017

Impact of “flexible” medication access in diabetes: Ability to tailor treatment to meet individual patient needs, according to best practices outlined by clinical practice guidelines


Inconsistent Approach Across Jurisdictions Product NS ON BC NIHB Onglyza

- Exception Status Drug

- 3L add-on to MET/SU if NPH insulin not an option - Trial of insulin required

- on formulary - 2L add-on to MET if intolerance or contraindication to SU

- Special Authority

- 3L add-on to MET/SU if NPH insulin not an option

- Limited Use Benefit - 3L add-on to MET/SU (no mention of insulin)

Invokana - Exception Status Drugs

- 3L add-on to MET/SU if NPH insulin not an option - Trial of insulin required

- on formulary a) 2L add-on to MET if intolerance or contraindication to SU OR b) 3L add-on to MET/SU if insulin not an option

- Not Listed - Limited Use Benefit - 3L add-on to MET/SU (no mention of insulin)

Reproduction requires permission of J.L. Glennie Consulting Inc. 10 MET = metformin; SU = sulphonylurea; NPH = NPH insulin; 2L = 2nd line; 3L = 3rd line

Patient-Centricity: Health Policy and Patient Access Disconnect


Future Vision: • PWDs should have comparable access to diabetes medications • Drug funding policy alignment to support broader objective of improving diabetes

care and minimizing long-term DM health impacts • Diabetes medication access policy alignment will help ensure PWDs/MDs have

tools to control DM + delay/potentially avoid long term complications and related health system costs

Public Health Policy

Drug Access Policy

Can’t afford access policies that are inconsistent with

public health priorities

A CALL TO ACTION: Making Diabetes Medication Access Patient Centric

Dr. Katharina Kovacs Burns

Panel Discussion: Bringing Patient-Centricity to Diabetes Medication Access

October 24, 2017


1. What is Patient Centric/Centricity…… and why is it important for diabetes care?


2. What does the evidence say in support of patient-centric diabetes medication access and treatment?


Additional Benefit Related to Patient-Centric Diabetes Drug Adherence (T2)


3. What are some Patient-Centric steps we can take to tackle the challenges of

diabetes medication access & management?


Comprehensive & Individualized Approach to Chronic Disease/Diabetes management


Determined When & With ….. • Individualized care & treatment choices:

– as per previous slide – holistic care & ↑tailored care based on individualized preferences/experiences

– also need best available evidence

• Patient-centric diabetes HTA reviews • Policy approaches aligned across drug programs &

desired health outcomes – ↓ barriers, costs & burdens to support diabetes

management & prevention


Current State – Individual Care & Public Policy Disconnect

Desired State – Population Health to support Individual Treatment & Care

• Restrictions on access to & coverage of diabetes treatment & prevention programs

• Decisions are cost-focused • Society’s capacity to address

broader public health problems is ignored Population risk factors Diabetes epidemic

• Population risk prevention strategy

• Respect of patient-centred & tailored approach to diabetes treatment & care Align patient goals +

medical needs with the evidence

• Timely medication access • Call to Action approach


Patient outcomes & experiences measured and evaluated to show what difference actions have

made


CALL TO ACTION!

Thank you!

Using evidence to support position on Patient Centricity for diabetes medication access &

improved outcomes

SESSION #7: Bringing Patient Centricity to Diabetes ...Patient-Centricity: Health Policy and Patient...

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Transcript of SESSION #7: Bringing Patient Centricity to Diabetes ...Patient-Centricity: Health Policy and Patient...