Module 0: The Opening

Every resource spent is a choice made.

Every choice made is a life affected.

O you who seek to heal,

have you considered the weight of your decisions?

This is not a course about formulas.
It is a course about choices that save lives.

The Transformation of a Nation

Muscat, 1970. The Ministry of Health is born.

Before the Ministry

2
Hospitals in all of Oman
118
Infant deaths per 1,000 births

By 2022

85+
Hospitals from Musandam to Dhofar
8.8
Infant deaths per 1,000 births

118 → 16 → 8.8

Infant mortality per 1,000 births

1970 → 2002 → 2022

In one generation, Oman saved 109 children per thousand.
Life expectancy rose from 49 to 77 years.

Have you not witnessed this miracle?

Then consider what comes next.

The Story of Oregon's Choice:

In 1994, Oregon faced a crisis: Medicaid couldn't cover everything. Rather than ration secretly, they created a public priority list. Condition-treatment pairs were ranked by cost-effectiveness and public values. Hip replacements ranked higher than cosmetic surgery. Life-saving treatments for rare cancers ranked lower than vaccines preventing thousands of cases.

The explicit trade-offs were controversial—but transparent. Oregon proved that rationing happens everywhere; the choice is whether to do it openly or hide it.

You are an Oregon health official in 1994. Medicaid cannot cover everything. What do you do?

Path A: Ration secretly like other states Continue with behind-closed-doors decisions about who gets what care.
Outcome: Public distrust grows. Accusations of unfairness and hidden agendas. No one understands why their treatment was denied.
Path B: Create a transparent priority list Publish rankings based on cost-effectiveness and public values. Let everyone see the trade-offs.
Outcome: Controversy erupts, but the public understands. Trust builds over time. Oregon becomes a model for honest healthcare rationing.

This is the question that haunts every health system.

5.3%
Oman's GDP on healthcare (2020)
$2M+
Cost of one gene therapy dose
10+
New therapies approved yearly

Innovation outpaces budgets. Choices must be made.

What is Health Technology Assessment?

By the end of this course, you will be able to:

  • Define HTA and explain its role in healthcare decision-making
  • Calculate and interpret QALY and ICER values
  • Apply Oman's cost-effectiveness threshold correctly
  • Conduct Budget Impact Analysis over a 4-year horizon
  • Perform mandatory sensitivity analyses
  • Identify appropriate comparators for different scenarios

A multidisciplinary process that uses scientific evidence to determine the value of health technologies.

Behold the Seven Principles:

1. Every resource spent is a choice made.

2. Value must be measured, not assumed.

3. The comparator defines the question.

4. A QALY is a year of life, lived well.

5. Uncertainty must be explored, not hidden.

6. Affordability is not the same as value.

7. Transparency protects the public trust.

Every resource spent is a choice made.

Module 1: The Question

The comparator defines the question.

Have you not considered

that every comparison reveals truth differently?

Compare a new drug to water, and it seems miraculous. Compare it to the best existing treatment, and its true value emerges.

The Tale of Two Oncologists

Sultan Qaboos Comprehensive Cancer Care Centre, Muscat

Dr. Fatima and Dr. Ahmed both treat the same cancer. Dr. Fatima's patient receives the new immunotherapy at 18,000 OMR. Dr. Ahmed's patient receives chemotherapy at 4,000 OMR.

Both patients have similar outcomes. The immunotherapy works — but so does the chemotherapy for this specific case.

Who chose wisely? The answer depends on what you compare against.

"A new technology without a comparator is like a scale with only one weight — it cannot measure value."

Decision Tree: Choosing the Comparator

Is there an authorized, reimbursed treatment for this indication?
YES
Use the standard of care as comparator
NO
Use Best Supportive Care (BSC)

What makes a valid comparator?

It must be authorized for the indication.

It must be reimbursed and available.

It must be evidence-based with proven efficacy.

It must be what the new technology will actually replace.

Oman's Epidemiological Profile

Ministry of Health, 2022
"When local data is unavailable, international epidemiological references are acceptable with a preference for data from GCC countries."
4.5M
Population (2023)
~45%
Under age 30
Rising
NCDs burden

And when they asked about unmet need,

the wise answered:

"Clearly articulate the specific public health need that is not fully addressed — areas such as early detection, low cure rates, therapy resistance, adherence issues, or severe side effects."

— Oman HTA Guidelines, 2024

Module 1 Quiz

When no effective therapy exists for a rare disease, what should be used as the comparator?

The comparator defines the question.

Module 2: The Evidence

Value must be measured, not assumed.

O you who practice medicine,

do you not see that claims require proof?

The Tale of Two Studies

Clinical Trial

500 patients, strict inclusion criteria, controlled conditions

Shows efficacy

Real-World Study

5,000 patients, routine practice, diverse population

Shows effectiveness

Both are needed. Neither alone is sufficient.

What outcomes truly matter?

Mortality: Does it extend life? (Overall Survival)

Morbidity: Does it reduce suffering? (Event-free survival)

Quality of Life: Does it improve daily experience? (PROs)

Function: Can patients return to work, to family, to life?

Hard vs. Surrogate Endpoints

Hard Endpoints (Preferred)

Overall survival, major clinical events, mortality

Direct patient benefit — no extrapolation needed

Surrogate Endpoints

Tumor response, biomarkers, lab values

Require validation that they predict hard outcomes

A tumor that shrinks (surrogate) may not always translate to longer life (hard endpoint). Validate the link before trusting the measure.

Decision Tree: Evidence Synthesis

Are there multiple RCTs available?
YES
Conduct meta-analysis or network meta-analysis
NO
Is there one pivotal trial?
Justify the choice, assess transferability

And the guidelines commanded:

"Utilize the Gulf countries Joint Clinical Assessment as the primary source of evidence for the investigated health technology, if available."

— Oman HTA Guidelines, Section 2

Regional collaboration strengthens individual nations.

Survival Analysis: Extrapolating Beyond the Trial

When trials are short but diseases are long-lived, we must extrapolate survival curves carefully using parametric models (Weibull, log-normal, Gompertz).
Kaplan-Meier
Observed data
Parametric
Extrapolation
Hazard Ratio
Relative effect

Justify model choice. Test sensitivity to alternative extrapolations.

Value must be measured, not assumed.

Module 3: The Balance

Affordability is not the same as value.

Have you pondered the difference

between cost and worth?

A cheap treatment that does not heal is expensive. An expensive treatment that cures may be the greatest bargain.

Decision Tree: Type of Economic Evaluation

Does the new technology show statistically significant improvement in primary endpoints?
YES
Cost-Utility Analysis
Measure outcomes in QALYs
NO
Cost-Minimization
Outcomes assumed equal

The Four Types of Evaluation

Cost-Benefit
All outcomes in OMR
Rarely used (ethical issues)
Cost-Minimization
When outcomes equal
Cost-Effectiveness
Natural units (LY, events)
Cost-Utility
Preferred: QALYs

Perspective: Who Bears the Cost?

Healthcare Perspective (Mandatory)

All direct medical costs: drugs, hospitalization, diagnostics, nursing, palliative care — regardless of who pays.

Societal Perspective (Optional)

Broader costs: transportation, caregiver burden, lost productivity, school impact.

Oman Requirement
"The healthcare perspective is mandated as the base-case."

How far must we look into the future?

For chronic diseases like diabetes or heart disease, look to the lifetime horizon. For acute illness, a shorter window may suffice — but justify your choice.

Discount Rate: 3% per year

Applied to both costs and outcomes (Oman requirement)

Examples: Time Horizons by Disease

Diabetes (Type 2)

Horizon: Lifetime

Complications develop over decades (nephropathy, retinopathy, CVD)

Acute Infection

Horizon: Weeks to months

Resolution or death occurs quickly

Cancer

Horizon: 5-10 years or lifetime

Survival curves, recurrence patterns

Cardiovascular

Horizon: Lifetime

Secondary prevention, long-term outcomes

NCDs account for a growing share of Oman's disease burden.

Affordability is not the same as value.

Module 4: The Measure

A QALY is a year of life, lived well.

Consider two patients.

Patient A

Lives 5 more years
In constant pain
Cannot work or enjoy family

Patient B

Lives 3 more years
In good health
Returns to full life

Which outcome is truly better?

The QALY Formula

QALY = Life Years × Utility

Where utility = 1 (perfect health) to 0 (death)

Calculating the Two Patients

Patient A: 5 years × 0.4 utility = 2.0 QALYs

Patient B: 3 years × 0.85 utility = 2.55 QALYs

Patient B has more quality-adjusted life, despite fewer years.

And thus the wise declared:

"A QALY treats all people equally. A year of life has the same value for the young and the old, the rich and the poor, the powerful and the humble."

This is both its strength and its limitation.

Measuring Utility: EQ-5D

Preferred Instrument
EQ-5D is the preferred utility instrument, ideally with GCC/Oman-specific value sets when available.
Mobility
Walking ability
Self-Care
Washing, dressing
Activities
Work, family, leisure
Pain
Discomfort level
Anxiety
Depression

Patient-Reported Outcomes (PROs) capture what matters most to patients.

Real Case: Cancer Therapy in Muscat

Illustrative Example: Royal Hospital Oncology

Outcome Standard Care New Therapy Difference
Life Years 2.5 4.0 +1.5
Utility (EQ-5D) 0.65 0.70 +0.05
QALYs 1.63 2.80 +1.17

Note: This is an illustrative example based on Oman HTA methodology.

A QALY is a year of life, lived well.

Module 5: The Ratio

Every resource spent is a choice made.

Now the question becomes:

How much for each year of quality life?

The ICER Formula

ICER = ΔCost / ΔQALY

Incremental Cost per Quality-Adjusted Life Year Gained

Translation: "How many extra rials do we spend for each additional QALY?"

Continuing the Royal Hospital Case

Adding Cost Data

Measure Standard New Therapy Incremental
Total Cost (OMR) 8,500 18,200 +9,700
QALYs 1.63 2.80 +1.17

ICER = 9,700 / 1.17 = 8,291 OMR/QALY

The Cost-Effectiveness Plane

Northwest: REJECT

More costly, less effective

Northeast: TRADE-OFF

More costly, more effective

Southwest: TRADE-OFF

Less costly, less effective

Southeast: DOMINANT

Less costly, more effective

When a technology dominates,

the decision is clear.

It costs less AND heals more. Accept without hesitation.

Decision Tree: The Four Quadrants of Value

Is the new technology MORE effective than current care?
YES
Is it also LESS costly?
YES
DOMINANT
Always adopt
NO
TRADE-OFF
Calculate ICER
NO
Is it LESS costly?
YES
TRADE-OFF
Calculate ICER
NO
DOMINATED
Never adopt

Every resource spent is a choice made.

Module 6: The Threshold

Value must be measured, not assumed.

If ICER is 8,291 OMR per QALY...

Is that good or bad?

We need a threshold — a line that separates "worth it" from "not worth it."

Oman's Cost-Effectiveness Threshold

CET = GDP per capita × Multiplier

Baseline: 1× GDP per capita

~8,000
OMR GDP per capita (approx.)
1-3×
Multiplier range
Data Source
GDP per capita figures from Central Bank of Oman (annually updated). Use the most recent official figure at time of submission.

But not all conditions are equal.

Orphan diseases: Multiplier = 2×

Priority diseases (cancer): Multiplier = 2×

Major relative health gain: Up to 3×

Society is willing to pay more for treating the sickest and the rarest.

Decision Tree: Is It Cost-Effective?

Is ICER below the calculated threshold?
YES
Cost-Effective
Consider for reimbursement
NO
Are there special circumstances? (Soft threshold)
Negotiate or decline

Back to Our Case

Royal Hospital Cancer Therapy Decision

ICER: 8,291 OMR/QALY

Disease: Cancer (priority) → Multiplier = 2×

Threshold: 8,000 × 2 = 16,000 OMR/QALY

8,291 < 16,000 → COST-EFFECTIVE

Value must be measured, not assumed.

Module 7: The Budget

Affordability is not the same as value.

Have you not seen the difference

between a wise purchase and a breaking flood?

The Story of Sofosbuvir

United States, 2014: Gilead launches Sovaldi (sofosbuvir), the first cure for Hepatitis C. It costs $84,000 per patient for a 12-week course. Clinical trials show 90%+ cure rates. The ICER is highly favorable—preventing liver failure, cirrhosis, transplants, and cancer.

"This is cost-effective!" the analysts declared. Payers disagreed.

Why? Consider the scale.

How many Americans had Hepatitis C?

3.2M
Americans with chronic Hep C
$84,000
Cost per patient
$268B
Total potential cost

Cost-effective per person. Unaffordable at scale. Medicaid programs rationed access.

You are a Medicaid director in 2014. Sovaldi costs $84,000/patient. 3.2 million patients need it. What do you do?

Path A: Fund treatment for all patients immediately Approve Sovaldi for everyone with Hepatitis C regardless of disease stage.
Outcome: Budget collapses. $268 billion cost forces cuts to cancer care, mental health, and preventive services. Other patients suffer.
Path B: Implement tiered access based on disease severity Prioritize patients with advanced liver disease. Others wait.
Outcome: Controversy and lawsuits follow, but budget survives. Some patients progress while waiting. Explicit rationing is painful but sustainable.
Path C: Negotiate price reductions aggressively Use collective bargaining, competition from generics, and volume discounts to reduce costs.
Outcome: Takes time, but prices eventually drop 90%. By 2020, treatment becomes affordable. Patience and negotiation win.

Two Questions, Two Answers

Cost-Effectiveness Analysis

"Is the value worth the price?"

Per-patient perspective

✓ YES

Budget Impact Analysis

"Can we afford it at scale?"

Population perspective

✗ NOT YET

Both answers are true. Both must inform the decision. This is why Oman requires BOTH analyses.

Oman's BIA Requirements

4 Years
Projection horizon
0%
Discount rate (no discounting)
Gradual
Patient uptake assumption

BIA includes only costs covered by the healthcare payer — the Ministry of Health.

The Diabetes Drug: Budget Impact Over 4 Years

Item Year 1 Year 2 Year 3 Year 4 Total
Patients treated 40,000 80,000 120,000 160,000 —
New therapy cost (OMR) 8M 16M 24M 32M 80M
Avoided complications -1M -3M -5M -8M -17M
Net impact (OMR) 7M 13M 19M 24M 63M

Gradual uptake (10%→40% of eligible patients over 4 years)

And so the decision-makers asked:

"What can we negotiate?"

The Resolution: The Ministry negotiated a phased introduction with the manufacturer. Year 1: high-risk patients only. Year 2: expand to moderate-risk. Price reduced 20% in exchange for volume guarantees.

Both value AND affordability were served.

Affordability is not the same as value.

Module 8: The Uncertainty

Uncertainty must be explored, not hidden.

Have you not seen how confidence can deceive?

The Tale of the Confident Analyst:

An analyst presented his model: "This drug costs 12,000 OMR per QALY. It is cost-effective." The committee approved.

One year later, real-world data showed the drug worked half as well as trials suggested. The true ICER was 28,000 OMR per QALY.

Had he explored uncertainty, he would have known: "There is only a 40% chance this drug is cost-effective."

Decision Tree: Sensitivity Analysis

Deterministic SA (Mandatory)
Change each input by ±10%
Is there significant parameter uncertainty?
YES
Probabilistic SA
Run 1,000+ iterations
LOW
Scenario analysis may suffice

The Tornado: Finding What Matters

The Story of Herceptin's Approval:

In 2006, NICE evaluated Herceptin for early breast cancer. The drug cost £20,000 per patient. Clinical trials showed survival benefits, but follow-up was short—survival estimates were extrapolated. NICE's sensitivity analysis revealed everything hinged on one uncertain number: long-term survival. If the extrapolation was optimistic, the ICER was £18,000/QALY (acceptable). If pessimistic, £40,000/QALY (borderline).

NICE approved with conditions, requiring real-world survival monitoring. The tornado diagram had revealed where uncertainty mattered most.

You are a NICE analyst in 2006. Herceptin shows promise, but survival data is uncertain. The ICER could be anywhere from acceptable to borderline. What do you recommend?

Path A: Approve based on optimistic extrapolation Trust the trial data and approve at the lower ICER estimate.
Outcome: If extrapolation proves wrong, resources are wasted on a less effective treatment than assumed. Opportunity cost: other patients lose access to better interventions.
Path B: Reject until long-term survival data is available Wait 5-10 years for definitive survival outcomes before approving.
Outcome: Potentially effective treatment delayed for years. Patients who could benefit today are denied access. If the drug works, you caused preventable deaths.
Path C: Approve with mandatory real-world monitoring Grant access now, but require ongoing data collection to verify survival assumptions.
Outcome: Patients get access. Evidence accumulates. If outcomes disappoint, the decision can be revised. Uncertainty is managed, not ignored.

Oman requires: Display at least the top 10 most impactful parameters.

What does honest uncertainty look like?

The Analyst's Honest Report
"Our base-case ICER is 8,291 OMR per QALY. However, if survival is 20% lower than trials suggest (a plausible scenario given limited follow-up), the ICER rises to 14,500 OMR per QALY.

At the threshold of 16,000 OMR/QALY, there is an 85% probability this technology is cost-effective."

This is decision-making with eyes open.

Cost-Effectiveness Acceptability Curve

The CEAC shows the probability that a technology is cost-effective at different willingness-to-pay thresholds. It answers: "How confident can we be?"
50%
at 5,000 OMR/QALY
85%
at 10,000 OMR/QALY
95%
at 16,000 OMR/QALY

Plot probability of cost-effectiveness (y-axis) against WTP threshold (x-axis)

Uncertainty must be explored, not hidden.

Module 9: The Decision

Transparency protects the public trust.

Now all threads come together.

The evidence, the cost, the value, the uncertainty.

Oman's HTA Journey: The Roadmap

2024

First Edition of HTA Guidelines

Ministry of Health publishes comprehensive methodology

1-2 yrs

Short-term: Capacity Building

Train-the-trainers, innovative pharmaceuticals focus

3-5 yrs

Medium-term: Expansion

Medical devices, Oman-specific threshold

6-10 yrs

Long-term: Full Transparency

Publish all reports, revision of decisions

And when the 21 experts gathered in Muscat...

October 27, 2022: Twenty-one experts from the Ministry of Health, Sultan Qaboos Cancer Centre, and the Royal Hospital gathered for an advanced HTA training. They were asked: "What do you want Oman's HTA system to become?"

Their answers would shape the nation's healthcare future.

The Voice of Oman's Experts

95%
Prefer Multi-Criteria Decision Analysis
90%
Demand full transparency
81%
Want local data mandated

When asked about cost-effectiveness thresholds, 57% chose explicit soft thresholds — flexible enough for special cases, firm enough to guide decisions.

And what of transparency?

The Story of PHARMAC's Transparency:

New Zealand's PHARMAC publishes every drug funding decision with full reasoning. When they declined to fund a cancer drug in 2010, patients were angry—but could see exactly why: the cost per QALY exceeded thresholds, and budget impact would defund other treatments. Contrast this with systems that simply say "not approved." PHARMAC faces criticism, but surveys show New Zealanders trust the process even when they disagree with decisions.

Transparency doesn't prevent controversy—it makes controversy productive.

You are a health ministry official deciding how to communicate drug funding decisions. What approach do you take?

Path A: Keep decisions confidential Simply announce "approved" or "not approved" without explanation. Avoid public scrutiny.
Outcome: No immediate criticism, but suspicion grows. Conspiracy theories flourish. When a denial affects a sympathetic patient, the backlash is devastating—and you have no defense.
Path B: Publish full reasoning for every decision Show the cost-effectiveness data, the budget impact, the trade-offs considered.
Outcome: Initial criticism is intense. But over time, the public learns to engage with evidence. Trust builds. Even those who disagree respect the process. Legitimacy is earned.

Transparency is not weakness. It is the armor of legitimacy.

Decision Tree: The Transparency Ladder

Level 0: Nothing published (current state for 95% of Oman)
Level 1 (Years 1-5): Recommendations published
Level 2 (Years 3-5): Clear timelines established
Level 3 (Years 6-10): Full critical appraisal reports published

Oman Vision 2040

The Promise
"To establish a transparent healthcare system that promotes justice and delivers high-quality services... to maintain sustainable and continuous health funding... to foster leadership in scientific research and health innovation."

HTA is how Oman will keep this promise.

Transparency protects the public trust.

Final Assessment

You have journeyed through the seven principles.

The Seven Principles

1. Every resource spent is a choice made.

2. Value must be measured, not assumed.

3. The comparator defines the question.

4. A QALY is a year of life, lived well.

5. Uncertainty must be explored, not hidden.

6. Affordability is not the same as value.

7. Transparency protects the public trust.

Final Quiz (1/10)

1. What is Oman's baseline cost-effectiveness threshold?

Final Quiz (2/10)

2. What discount rate does Oman require for economic evaluations?

Final Quiz (3/10)

3. Budget Impact Analysis projects over how many years?

Final Quiz (4/10)

4. Which utility instrument is preferred for measuring health-related quality of life?

Final Quiz (5/10)

5. What type of sensitivity analysis is MANDATORY in Oman?

Final Quiz (6/10)

6. For orphan diseases, what threshold multiplier applies?

Final Quiz (7/10)

7. Which perspective is MANDATORY for the base-case analysis?

Final Quiz (8/10)

8. When a new therapy is MORE effective AND LESS costly, it is called:

Final Quiz (9/10)

9. What source should be used first for clinical evidence if available?

Final Quiz (10/10)

10. The ICER formula is:

You have completed the journey.

Go forth and assess with wisdom.

Based on the Oman HTA Guidelines, First Edition 2024
Ministry of Health, Sultanate of Oman

Note: Case studies are illustrative examples based on Oman HTA methodology.